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Inclusive Dental Implant System Restorative

1. Fabricate a Cast Bar 1 2 3 4 Remove the try in prosthesis from the working model and attach an Inclusive Multi Unit Gold Plastic Coping with plastic burnout sleeve to each multi unit abutment analog Hand tighten with the Inclusive Guide Pin provided Using the plaster silicone matrix created from the approved wax try in as a guide for size and position follow waxing procedures to wax the bar pattern around the copings and plastic sleeves The bar pattern should fit well within the matrix s borders to assure adequate room in the final prosthesis for all bar components without sacrificing excessive material thickness Unscrew the guide pins and remove the wax bar pattern from the working model Follow procedures to invest burn out and cast the bar with the appropriate alloy Finish the cast bar by divesting refining as needed and polishing When making alterations be sure not to adjust the incorporated coping s multi unit abutment connection regions Changes to these machined specifications will result in improper seating and or decreased retention B Laboratory Fabricate an Immediate Bar 1 2 Remove the try in prosthesis from the working model and attach an Inclusive Multi Unit Gold Bar Coping to each multi unit abutment analog Hand tighten with the Inclusive Guide Pin provided Follow procedures to measure lute and solder bar segments to the bar copings NOTE If desired measurement and luting
2. Driver Selection on page 4 Using an existing denture or other prosthesis place a hole in the position directly above the placement of each multi unit titanium temporary The holes should puncture all the way through the prosthesis Resting the denture on the ridge with the titanium temporaries protruding from the apex carefully fill the hole around each titanium temporary with acrylic flowable composite or other material suitable for securing the temporary to the denture Follow procedures to cure the material being careful to keep the temporary s screw access channel free of adhesive Remove the prosthetic screw from each titanium temporary and remove the denture The temporaries should be captured within the denture Modify the denture as necessary Grind any protruding titanium from the upper side of the denture Fill any voids around the base of each titanium temporary on the underside of the denture with acrylic flowable composite or other suitable material and cure Reseat the temporary denture onto the ridge and replace the prosthetic screw into the multi unit titanium temporaries Using the appropriate driver in conjunction with a properly metered torque wrench tighten the prosthetic screws to 15 Ncm Fill the screw access channels with gutta percha silicone or other suitable temporary material Laboratory Fabricate the Stone Working Model 1 2 3 4 For impressions captured with the closed tray ind
3. build up and subsequent wear of the retention bands This would result in the device to perform with improper fit and function which would result in loss of retention for the prosthesis Sterilization All components and instruments are supplied NON STERILE Titanium abutments may be sterilized by Autoclave or Dry Heat sterilization using the following parameters 1 Autoclave sterilize using 121 C 250 F 15 20 psig at sea level for twenty 20 minutes minimum 2 Dry Heat sterilize using 170 C 338 F for two 2 hours minimum Locator Core Tools disassembled state only may be sterilized by Autoclave or Dry Heat sterilization using the following parameters 1 Autoclave sterilize using 121 C 250 F 15 20 psig at sea level for forty 40 minutes minimum 2 Dry Heat sterilize using 170 C 338 F for two 2 hours minimum 800 407 3379 www glidewelldirect com 41 Locator Abutment Features Lowest Vertical Height The total height of the Locator Attachment abutment plus male is only 3 17mm on an externally hexed implant and 2 5mm on a non hexed implant Locating Design Self locating design allows a patient to easily seat their overdenture without the need for accurate alignment of the attachment components Retention Inside And Out The patented Dual Retention innovation provides the Locator Attachment with greater retention surface area than ever before available with other attachments A combination of inside a
4. expired damaged or opened items will not be accepted for return m Amount credited will be based on invoice price less 15 percent for restocking fee m Shipping charges are the responsibility of the customer and will not be credited Product amp Pricing Changes Because products and equipment are continually undergoing refinement in design and manufacturing methods we reserve the right to improve modify or discontinue products and equipment or change pricing at any time without incurring any obligation and without prior notice Warranty Limited Warranty Prismatik Dentalcraft Inc Prismatik Dentalcraft Inc Prismatik is the manufacturer of dental products the product including Inclusive Dental Implants implants Prismatik and Glidewell Direct hereinafter are referred to collectively as Glidewell For a period from the original purchase date of seven 7 years for implants and six 6 months for ceramic blanks and any other product the warranty period Glidewell will at its option replace or refund the purchase price of any product to the original purchaser user that is returned due to defects in material and manufacture NO GUARANTEE OR WARRANTY IS IMPLIED OTHER THAN EXPRESSLY STATED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE Glidewell shall not be liable for any incidental or consequential damages whether foreseeable or not caused by defects in the product or de
5. 20 CONTRAINDICATIONS 20 RESTORATIVE PROCEDURE WITH TITANIUM ABUTMENTS 21 INCLUSIVE TITANIUM ESTHETICABUTMENT 22 PRODUCT DESCRIPTION 22 MATERIAL COMPOSITION 22 STERILITY 22 INTENDED USE 22 CONTRAINDICATIONS 22 RESTORATIVE PROCEDURE WITH TITANIUM ESTHETIC ABUTMENTS 23 INCLUSIVE UCLA ABUTMENT 25 PRODUCT DESCRIPTION 25 MATERIAL COMPOSITION 25 STERILITY 25 INTENDED USE 26 CONTRAINDICATIONS 26 CASTING CUSTOM ABUTMENTS WITH UCLAS 26 INCLUSIVE TITANIUM SCREW GUIDE PIN 28 PRODUCT DESCRIPTION 28 800 407 3379 www glidewelldirect com MATERIAL COMPOSITION 28 STERILITY 28 INTENDED USE 28 CONTRAINDICATIONS 29 ATTACHMENT PROCEDURE 29 RETRIEVAL PROCEDURE 29 INCLUSIVE MULTI UNIT ABUTMENT 31 PRODUCT DESCRIPTION 31 MATERIAL COMPOSITION 32 STERILITY 32 INTENDED USE 32 CONTRAINDICATIONS 32 IMPLANT ORIENTATION 32 RESTORATIVE PROCEDURE WITH MULTI UNIT ABUTMENTS 33 LOCATOR ABUTMENT 41 INTENDED USE 41 CONTRAINDICATIONS 41 CAUTION 41 SINGLE USE DEVICES 41 STERILIZATION 41 LOCATOR ABUTMENT FEATURES 42 RESTORATIVE PROCEDURE WITH LOCATOR ABUTMENTS 42 POLICIES AND WARRANTY 48 LOCATOR is a registered trademark of Zest Anchors LLC 800 407 3379 www glidewelldirect com Restorative Considerations Scope This manual outlines the appropriate procedures for using Inclusive Prosthetic Components in the process of restoring endosseous dental implants with a common range of prosthetic solutions such as single or multiple unit cro
6. After the acrylic resin has cured remove the denture and discard the White Block Out Spacer Use a bur to remove excess acrylic and polish the denture base before changing to the final male Use the Locator Male Removal Tool 48397 attached to the Locator Core Tool 88393 to remove the Black Processing Replacement Male from the metal denture cap The sharp circular edge on the end of the removal tool should be wedged tightly down into the very bottom of the Male so that it will catch the inside of the Male and pull it at an angle out of the metal housing To discard the Male from the tip on the Core Tool point the tool down and away from you and tighten the Male Removal Tool clockwise back onto the Core Tool This will activate the removal pin and dislodge the Male from the tip end of the Male Removal Tool The Locator Male Seating Tool of the Locator Core Tool 88393 is used to firmly push a Locator Replacement Male into the metal denture cap The Replacement Male must seat securely into place level with the rim of the cap NOTE The Replacement Male will not stay on the tool when it is turned upside down due to the varying sizes of males available It is best to hold the denture with the base side down and snap the male into the metal denture cap 800 407 3379 www glidewelldirect com 44 10 Instruct the patient in the path of insertion Have the patient insert and remove the appliance several times B Laboratory Placement of th
7. WARNING PRECAUTIONS MRI STERILITY STORAGEAND HANDLING PROSTHETIC COMPONENT TYPES COMPATIBLE IMPLANT SYSTEMS RESTORATIVE PROTOCOLS DRIVER SELECTION TORQUE VALUES INCLUSIVE HEALING ABUTMENT UP PWWWNNP RP PPP gt PRODUCT DESCRIPTION MATERIAL COMPOSITION STERILITY INTENDED USE CONTRAINDICATIONS PLACEMENT PROCEDURE INCLUSIVE TEMPORARY ABUTMENT BITE VERIFICATION CYLINDER QN ON OA OA OA OA G PRODUCT DESCRIPTION MATERIAL COMPOSITION STERILITY INTENDED USE CONTRAINDICATIONS TEMPORARY ABUTMENT PLACEMENT PROCEDURE INCLUSIVE TRANSFER COPING VO O OQ CO o o CO 11 PRODUCT DESCRIPTION MATERIAL COMPOSITION STERILITY INTENDED USE CONTRAINDICATIONS CLOSED TRAY IMPRESSION PROCEDURE OPEN TRAY IMPRESSION PROCEDURE INCLUSIVE SCANNING ABUTMENT 12 12 12 12 12 13 15 PRODUCT DESCRIPTION MATERIAL COMPOSITION 800 407 3379 www glidewelldirect com 15 15 STERILITY 15 INTENDED USE 15 CONTRAINDICATIONS 16 DIGITAL IMPRESSION PROCEDURE 16 INCLUSIVE IMPLANT ANALOG 17 PRODUCT DESCRIPTION 17 MATERIAL COMPOSITION 17 STERILITY 17 INTENDED USE 17 CONTRAINDICATIONS 17 IMPLANT ANALOG PROCEDURE 17 INCLUSIVE ABUTMENT ANALOG 18 PRODUCT DESCRIPTION 18 MATERIAL COMPOSITION 18 STERILITY 18 INTENDED USE 18 CONTRAINDICATIONS 18 ABUTMENT ANALOG PROCEDURE 18 INCLUSIVE TITANIUM ABUTMENT 20 PRODUCT DESCRIPTION 20 MATERIAL COMPOSITION 20 STERILITY 20 INTENDED USE
8. actual fixture in the oral environment Material Composition Sterility Titanium alloy Ti6A14V Non sterile Intended Use Inclusive Implant Analogs are to be incorporated in the production of a working model to replicate the position and orientation of implants seated in the patient s mouth Contraindications Inclusive Implant Analogs are not intended for use in the oral environment Implant Analog Procedure B Select an Inclusive Implant Analog Select the appropriate Inclusive Implant Analog based on the system and platform size of the implant seated in the patient s mouth B Attach the Implant Analog 1 2 3 4 Follow the elastomeric impression procedure for the desired impression technique open tray or closed tray using its associated transfer coping Mount the Inclusive Implant Analog on the transfer coping Be sure the analog seats flush against the transfer coping and the non rotational features of the connection are fully engaged Fasten the transfer coping to the implant analog by using the appropriate driver to hand tighten the transfer coping screw Proceed with the fabrication of a stone model using standard laboratory techniques Upon separation the implant analog is a part of the master cast replicating the position of the implant seated in the oral cavity 800 407 3379 www glidewelldirect com 17 Inclusive Abutment Analog Product Description h Inclusive Abutment Analogs ar
9. implant abutment interface The apical portion of a straight multi unit abutment is threaded for integration with the internal cavity of a seated implant For abutment delivery the occlusal surface features a male hex head compatible with the multi unit driver recommended by the implant manufacturer Angled multi unit abutments of 17 degrees or 30 degrees enable clinicians to compensate for the divergence of seated implants or to otherwise accommodate an angled path of insertion Angled multi unit abutments feature an anti rotational connection interface specific to the matching implant platform and are attached to the implant fixture with an angled multi unit abutment screw Both straight and angled multi unit abutments feature a female connection port at the coronal apex to allow for the attachment of a screw retained or fixed removable dental prosthesis with a multi unit restorative screw Inclusive Prosthetic Screw 17 Angle 30 Angle Straight Each angled Inclusive Multi Unit Abutment is packaged with a separate retaining screw Inclusive Angled Multi Unit Abutment Screw compatible with the restorative instrumentation of the specified implant system Angled Multi Unit Abutment Screw 800 407 3379 B www glidewelldirect com 31 Material Composition Sterility Titanium alloy TiGAlAV Sterile Intended Use Inclusive Multi Unit Abutments are prosthetic components directly connected to endosseous dental implants and inten
10. instruments which may scratch the abutment surface Examine patients for signs of inflammation around the implant abutments and for implant mobility Use a 30 Ncm torque wrench to make sure the Locator Implant Abutment is tight before dismissal 800 407 3379 www glidewelldirect com 47 Policies and Warranty Ordering Information Order at www glidewelldirect com or call Glidewell Direct at 1 800 407 3379 Our product specialists are committed to answering questions in a timely fashion to ensure your ordering is easy and efficient We are available Monday Friday from 6 a m 5 p m PST Shipping Policy m Orders placed after 3 p m PST will be processed on the following business day Business days do not include Saturdays Sundays or U S holidays m Online shopping cart available to U S customers only Terms All accounts are payable within 30 days of invoice date Accounts not paid within the stated terms will be subject to COD status and a late charge of 2 percent of the unpaid balance We accept American Express Visa MasterCard and Discover All prices are subject to change without notice Product Return Policy Products may be returned at the customer s expense for credit within 30 days of invoice date All returned products must meet the following conditions m A copy of the original invoice must accompany the products m Products must be packaged to arrive at the seller s facility undamaged m Discontinued obsolete
11. may offer implant drivers marked to facilitate proper orientation of implants upon final seating These markings may not apply to the ideal implant orientation for angled multi unit abutments Proper treatment planning is essential to restorative success 800 407 3379 B www glidewelldirect com 32 Restorative Procedure with Multi Unit Abutments B Place the Multi Unit Abutment 1 Select the appropriate Inclusive Multi Unit Abutment based on platform size endosseous implant angle and depth of the soft tissue well The margin should be 1 to 2 mm supragingival 2 Remove the lid from the aseptic vial and retrieve the abutment by lifting the plastic abutment carrier straight out To maintain the sterility of the multi unit abutment be careful to handle only by the plastic carrier For Straight Abutments 3 Using the plastic carrier seat the abutment into the implant and hand tighten Remove the plastic carrier by pulling the apex of the carrier toward the facial It is strongly recommended that a radiograph of the connection site be taken to confirm complete seating of the abutment before proceeding 4 Using the appropriate driver in conjunction with a properly metered torque wrench tighten the multi unit abutment to the implant manufacturer s recommended torque value see Torque Values on page 5 C For Angled Abutments 3 Using the plastic carrier seat the abutment into the implant until the anti rotational features
12. of the bar segments can be performed intraorally and a stone working model produced from the luted bar by connecting Inclusive Multi Unit Abutment Analogs to the luted bar copings E Laboratory Design and Mill a CAD CAM Bar 1 2 3 4 5 For a stone model poured from a closed tray indirect impression remove the closed tray multi unit impression copings by twisting each coping counterclockwise Hand tighten an Inclusive Multi Unit Scan Abutment to each multi unit abutment analog by twisting the scanning abutment clockwise Follow manufacturer instructions for the particular intraoral scanner to capture the digital impression Remove the multi unit scan abutment by twisting counterclockwise Follow CAD CAM software and milling procedures to design and mill the bar B Try in the Bar 1 Confirm that the multi unit abutments seated on the endosseous implants are tightened to the implant manufacturer s recommended torque value see Torque Values on page 5 800 407 3379 B www glidewelldirect com 38 2 Seat the bar onto the multi unit abutments Hand tighten an Inclusive Prosthetic Screw into either distal most abutment 3 Examine the other abutments to confirm no separation or lifting of the bar has resulted from tightening the first Proceed to hand tighten each abutment in turn starting from the distal and moving forward alternating between sides of the ridge If a passive fit is achieved 4 Re
13. of the implant seated in the patient s mouth Seat the abutment completely into the implant analog on the working model making sure that the anti rotational features of the connection interface are fully engaged and the contours of the sculpted emergence profile are esthetically oriented For angled abutments the tapered side should be oriented nearest vertical along the same plane as the implant Insert the Inclusive Titanium Screw provided into the abutment s screw access hole and hand tighten using the appropriate driver Fabricate the restoration using conventional casting or CAD CAM techniques Veneer as necessary If a screw retained hybrid restoration is indicated lute the ceramic crown to the titanium abutment B Deliver the Final Restoration 1 2 3 Seat the titanium esthetic abutment or screw retained hybrid restoration completely into the implant making sure that the anti rotational features of the connection interface are fully engaged and the contours of the sculpted emergence profile are esthetically oriented For angled abutments the tapered side should be oriented nearest vertical along the same plane as the implant Insert the Inclusive Titanium Screw provided into the screw access hole and hand tighten using the appropriate driver It is strongly recommended that a radiograph of the connection site be taken to confirm complete seating of the abutment or hybrid restoration before proceeding Using the appr
14. processing the appliance place a Locator Denture Cap Processing Male Assembly onto each Female Analog in the master cast Make sure the Denture Cap Processing Male Assembly is fully seated 7 Set the teeth and wax the appliance Proceed with the processing technique of your choice through the boil out step 8 After boil out remove the Locator Denture Cap Processing Male Assembly Place a White Block Out Spacer over the head of each Female Analog The spacer is used to block out the immediate area surrounding the Locator Implant Abutment The space created will allow the full resilient function of the pivoting metal denture cap over the Locator Nylon Male 9 Reinsert the Locator Denture Cap Processing Male Assembly onto each Locator Female Analog leaving the White Block Out Spacer beneath it The Black Processing Replacement Male will maintain the overdenture in the upper limit of its vertical resiliency during the processing procedure NOTE If the dentist prefers to perform a chairside pick up of the Locator Denture Cap Processing Male Assembly use of the Locator Processing Spacer 88569 will create the exact space needed 800 407 3379 www glidewelldirect com 45 10 11 12 Complete the processing and discard the White Block Out Spacer Polish the denture base before changing to the appropriate Locator Nylon Replacement Male Use the Locator Male Removal Tool 8397 attached to the Locator Core Tool 88393 to remove th
15. prosthetic component not listed in the table above should be hand tightened only 800 407 3379 www glidewelldirect com 2 Inclusive Healing Abutment Product Description An Inclusive Healing Abutment is delivered post implant placement to close the implant connection and aid in soft tissue management during the healing phase Healing abutments may be delivered immediately single stage protocol or after an initial healing period two stage protocol depending upon implant stability Healing abutments are precisely machined from titanium alloy The apical portion of the healing abutment is threaded for integration with the internal cavity of a seated implant The occlusal surface of the healing abutment contains a female instrumentation port compatible with the restorative driver recommended by the implant manufacturer Each healing abutment is specific to the restorative platform of the seated implant Material Composition Sterility Titanium alloy Ti6AI4V Sterile Intended Use Inclusive Healing Abutments are prefabricated prosthetic components directly connected to endosseous dental implants when delayed loading is indicated intended to close the implant connection during endosseous and gingival healing Contraindications Inclusive Healing Abutments are transgingival components They are not intended for complete gingival submersion Placement Procedure B Select a Healing Abutment 1 Verify adequate primary st
16. remaining undercuts to prevent the added acrylic resin from locking the denture onto the abutment This can be accomplished by stacking more Block Out Spacers Insert a Locator Denture Cap Processing Male Assembly contained in package 8519 onto each Locator Implant Abutment leaving the White Block Out Spacer beneath it The Black Processing Replacement Male will maintain the overdenture in the upper limit of its vertical resiliency during the processing procedure Prepare a recess in the denture to accommodate the protruding Locator Denture Cap Processing Male Assembly There must be no contact between the denture and the titanium cap If the denture rests on the metal cap excess pressure on the implant will result Use the Chairside Lightcure Acrylic Resin Syringe Kit 9403 to light cure bond the Locator Denture Cap Processing Male Assembly into the denture or mix a permanent self curing acrylic and place a small amount in the recess of the denture and around the metal cap of the Locator Denture Cap Processing Male Assembly Insert the denture into position in the oral cavity Guide the patient into occlusion maintaining a proper relationship with the opposing arch Maintain the denture in a passive condition without compression of the soft tissue while the acrylic sets Excessive occlusal pressure during the setting time may cause tissue recoil against the denture base and could contribute to dislodging and wear of the nylon males
17. to the individual product information sections contained within this restorative manual Warning Do not reuse Inclusive Prosthetic Components labeled for single use as they are intended to be used on an individual patient only The reuse of such device may result in product contamination patient infection or failure of the device to perform as intended Precautions Inclusive Prosthetic Components may only be used for their intended purpose in accordance with general rules for restorative dental treatment occupational safety and accident prevention Improper technique associated with the use of these devices may result in adverse effects including but not limited to implant fracture or failure loss of supporting bone restoration fracture or failure and 800 407 3379 www glidewelldirect com 1 compromised oral function It is the responsibility of the licensed clinician or laboratory technician to determine the appropriate treatment protocols and device selection Inclusive devices should only be used for dental procedures with the implant systems they were designed for Prior to restorative treatment ensure that the required components instruments and ancillary materials are complete functional and available in the correct quantities If the indications and intended usage are not clearly specified treatment should be suspended until these considerations have been clarified Inspect all components prior to use Do not use any comp
18. to which information refers Trademarks Inclusive is a registered trademark of Prismatik Dentalcraft Inc This user manual makes reference to various products and brands owned by third party companies All third party trademarks are the property of their respective owners as follows ASTRA TECH IMPLANT SYSTEM is a registered trademark of Dentsply IH AB LLC BIOMET 3i is a trademark of BIOMET 3i LLC Br nemark System is a registered trademark of the Nobel Biocare group CAMLOG is a registered trademark of Camlog Biotechnologies AG CERTAIN is a registered trademark of BIOMET 3i LLC LOCATOR is a registered trademark of Zest Anchors LLC NEOSS is a registered trademark of Neoss Limited NobelActive is a registered trademark of the Nobel Biocare group NobelReplace is a registered trademark of the Nobel Biocare group PRIMACONNEX is a registered trademark of Keystone Dental Inc SCREW VENT is a registered trademark of Zimmer Dental Inc Snappy is a trademark of the Nobel Biocare group STRAUMANN is a registered trademark of Straumann Holding AG synOcta is a registered trademark of Straumann Holding AG Unigrip is a trademark of the Nobel Biocare group Prismatik Dentalcraft makes no claim to any of these third party companies or products nor any affiliation therewith Table of Contents RESTORATIVE CONSIDERATIONS SCOPE INTENDED USE CONTRAINDICATIONS
19. INCLLISIVE PROSTHETIC COMPONENTS Restorative Manual April 2014 800 407 3379 www glidewelldirect com GLIDEWELL DIRECT CLINICAL AND LABORATORY PRODUCTS ae Certificate e MN a n ENAN of Registration L aj QUALITY MANAGEMENT SYSTEM ISO 13485 2003 This is to certify that Prismatik Dentalcraft Inc a wholly owned subsidiary of Glidewell Laboratories 2212 Dupont Drive Irvine California 92612 USA Holds Certificate No FM 573328 and operates a Quality Management System which complies with the requirements of ISO 13485 2003 for the following scopo Design and manufacturing of dental restorative products For and on behalf of BSI VP Regulatory Affairs BSI Group America Inc Originally Registered 09 02 2011 Effective Date 09 02 2011 Expiry Date 09 01 2014 BSI CMDCAS Recognized Registrar This certificate remains the property o BSI and shall be returned immediately upon request An electronic certificate can be authenticated 5nine Printed copies can be validated at www bsigroup comClenDirectory To be read in conjunction with the scope above or the attached appendix Americas Headquarters 12110 Sunset Hills Road Suite 200 Reston VA 20190 USA Introducing Inclusive Prosthetic Components Founded in 2006 with the goal of expanding the availability of comprehensive dental implant therapy to patients across the economic spectrum Prismatik Dentalcraft reduces the com
20. The open tray transfer coping should be captured by the impression material B Record Implant Placement 1 2 Mount a corresponding implant analog on the Inclusive Open Tray Transfer Coping captured within the impression Fasten using the Inclusive Open Tray Transfer Coping Screw provided making sure to maintain a hold on the analog rather than the impression tray so as not to rotate the transfer coping in the impression material Proceed with the fabrication of a stone model using standard laboratory techniques Upon separation the implant analog is a part of the master cast replicating the position of the implant seated in the oral cavity 800 407 3379 www glidewelldirect com 14 4 Inclusive Scanning Abutments are used to transmit highly accurate position and angulation data of seated implants when scanned with an intraoral or desktop digital scanner Each scanning abutment consist of an abutment body manufactured from biocompatible PEEK material Retained within the abutment body by internal threading is a screw manufactured from titanium alloy An Inclusive Scanning Abutment is attached to the implant utilizing the internal screw which is compatible with the restorative instrumentation of the specified implant system Always use the internal screw to attach the scanning abutment to the implant tightening the screw to hold the scanning abutment in place Hand tighten only using the appropriate driver Do
21. ability of the implant before seating any Inclusive Healing Abutment 2 Select the appropriate Inclusive Healing Abutment based on the implant system platform size soft tissue depth and desired emergence profile B Place the Healing Abutment 1 Insert the Inclusive Healing Abutment into the internal connection cavity of the seated implant making sure it enters at the same angle as the implant to avoid potential damage that may result from cross threading 800 407 3379 B www glidewelldirect com 6 2 Rotate the Inclusive Healing Abutment clockwise until engaged with the internal threads of the implant connection cavity 3 Selectthe appropriate driver based on the implant system being utilized see Driver Selection on page 4 Using the selected driver advance threaded delivery of the Inclusive Healing Abutment until fully seated against the implant platform 4 Verify complete seating of the Inclusive Healing Abutment against the implant platform Utilize radiography to do so if clinically appropriate B Close the Flap If a soft tissue flap has been reflected to facilitate implant placement adapt the soft tissue tightly around the seated Inclusive Healing Abutment and suture into place 800 407 3379 www glidewelldirect com 7 Inclusive Temporary Abutment Bite Verification Cylinder Product Description Inclusive Temporary Abutments and Inclusive Bite Verification Cylinders are indicated for the fabrication of tem
22. al spacing and retention requirements 3 Using conventional waxing procedures add wax to the exterior of the UCLA plastic sleeve to form the custom abutment with the desired emergence profile margins and angulation NOTE If the wax form is going to exceed the height of the final shaped plastic sleeve the titanium screw should be removed and replaced with the Inclusive Guide Pin prior to waxing to ensure the screw access channel remains open 4 Once satisfied with the wax form use standard techniques to sprue the wax up Be sure to sprue so that the UCLA s waxing sleeve will stand perpendicular to the base of the investment ring Cast the UCLA Wax up 1 Unscrew and remove the wax up from the stone model If the wax up is attached to the model using the guide pin take care that the rotation of the guide pin during removal does not alter the sculpted shape of the wax up 2 Carefully examine the base and collar of the wax up to confirm the platform specific connection is free of wax and other debris 3 Follow investment procedures to invest the wax up When pouring the investment material pay special attention to ensure that the investment flows up and through the screw access channel 4 Follow burnout and casting procedures observing all material specifications and equipment instructions 5 Chemically divest the abutment Do not use sandblasting divestment techniques as the coarse grains will alter the machined precisio
23. bel Biocare NobelReplace NP RP wP 6 0 Straumann Bone Level nc RC Straumann Tissue Level NN RN synOcta WN synOcta Zimmer Dental Screw Vent 3 5 mm 4 5 mm 5 7 mm NOTE The availability of a particular type of prosthetic component varies by implant system and may be limited by geographical territory The platform specific compatibility of each component is indicated on the individual product label For a complete product listing please refer to the Inclusive Prosthetic Components Product Catalog or contact an Inclusive sales representative 800 407 3379 B www glidewelldirect com 3 Restorative Protocols With the exception of system specific drivers please refer to the Driver Selection section below the restorative protocols outlined in this manual are system independent Unless otherwise noted the same techniques apply regardless of which implant system is being used While every attempt has been made to document appropriate restorative procedures it is the responsibility of the clinician to be familiar with any protocols that may govern use of a specific implant system as determined or recommended by the system manufacturer For illustrative purposes all clinical and laboratory images displayed in this manual feature prosthetic components and drivers for the Inclusive Tapered Implant System Driver Selection For clinical convenience Inclusive Prosthetic Components are designed to be compatible with th
24. d during a digital scanning procedure to capture a seated implant s axis indexing feature orientation and position relative to adjacent dentition 800 407 3379 www glidewelldirect com 15 Contraindications Inclusive Scanning Abutments should not be used for elastomeric impressions or bite registrations Digital Impression Procedure B Select an Inclusive Scanning Abutment Select the appropriate Inclusive Scanning Abutment based on the implant system platform size and setting clinical or laboratory in which it is to be used If the abutment is to be placed intraorally verify adequate primary stability of the implant before seating The implant should demonstrate sufficient stability to withstand attachment and removal of the scanning abutment B Place the Scanning Abutment 1 If placing an Inclusive Clinical Scanning Abutment connecting to an implant in the patient s mouth ensure that the implant mating surface is free of bone soft tissue or other residue that may impinge full seating of the abutment connection feature If placing an Inclusive Laboratory Scanning Abutment connecting to an implant analog ensure that the analog mating surface is clear of residue that may inhibit full seating 2 Select the appropriate scanning abutment based on the platform of the implant or implant analog Inspect the scanning abutment prior to use Do not use a scanning abutment that is damaged or unclean 3 Insert the scanning abutme
25. ded to provide support and retention for multi unit screw retained restorations A 30 degree angled multi unit abutment must be used within 45 degrees of parallelism for a splinted restoration A 17 degree angled multi unit abutment must be used within 32 degrees of parallelism for a splinted restoration Contraindications The following conditions would contraindicate use of Inclusive Multi Unit Abutments Greater than 45 degrees divergence from parallel for a splinted restoration when using 30 degree angled multi unit abutments Greater than 32 degrees divergence from parallel for a splinted restoration when using 17 degree angled multi unit abutments Angled abutments should not be used to restore small diameter implants less than or equal to 3 0 mm in the posterior region Implant Orientation The axial tilt of an Inclusive Angled Multi Unit Abutment angular divergence from path of insertion is designed and manufactured to lie along a plane of the implant connection geometry as opposed to a corner or junction To maximize the angle correcting attributes of the multi unit abutment be sure to rotate the implant upon final seating so that one side of the internal connection geometry flat or lobe is oriented to serve as the base of angulation in accordance with the restorative treatment plan Path of implant insertion Axial tilt of abutment Orientation for Angled Multi Unit Abutments NOTE Some implant manufacturers
26. diate value and lasting quality From its beginnings until today Prismatik Dentalcraft has experienced an ever growing demand in support of its vision to make dental implant therapy more accessible to patients around the globe This growth has enabled the company to consistently expand and improve its offerings even in a time of widespread economic challenge The Inclusive brand has quickly established itself as a trusted name within the industry and Prismatik Dentalcraft as a manufacturer at the forefront of dental technology Thank you for choosing Prismatik You can place your trust in us Copyright O 2014 Prismatik Dentalcraft Inc Prismatik Dentalcraft Inc is not responsible for any damages or other liabilities including attorney fees resulting or claimed to result in whole or in part from actual or alleged problems arising out of the use of this information The techniques procedures and theories presented herein are provided in good faith and believed to be correct as of the date hereof Any dental professional viewing this presentation must make his or her own decisions about the use of the materials and techniques for specific situations No representations as to the completeness or accuracy of this information is given and no representations or warranties either expressed or implied of merchantability fitness for a particular purpose or of any other nature are made here under with respect to the information or the product
27. dling Inclusive Prosthetic Components should be stored in a dry location at room temperature in their original packaging Visually inspect all products to ensure seals and contents are intact prior to use For product specific handling instructions please refer to the individual product labels Prosthetic Component Types Prismatik Dentalcraft offers an extensive line of prosthetic components under the Inclusive brand name Healing Abutments Temporary Abutments Bite Verification Cylinders Transfer Copings Scanning Abutments Implant Analogs Abutment Analogs Titanium Abutments Titanium Esthetic Abutments UCLA Abutments Multi Unit Abutments Titanium Screws The Inclusive line of prosthetic components also features LOCATOR Abutments LOCATOR Attachments and related LOCATOR tools and accessories manufactured by Zest Anchors Escondido Calif Compatible Implant Systems Inclusive Prosthetic Components manufactured by Prismatik Dentalcraft are compatible with the following implant restorative platforms BIOMET 3i Certain 3 4 mm 4 1 mm 5 0 mm 6 0 mm u CAMLOG SCREV LINE 3 3 mm 3 8 mm 4 3 mm 5 0 mm 6 0 mm DENTSPLY Implants ASTRA TECH Implant System 3 0 X Small 3 5 4 0 Small 4 5 5 0 Large Inclusive Tapered Implant System 3 5 mm 4 5 mm Keystone Dental PrimaConnex sp RD WD Neoss 4 0mm Nobel Biocare Br nemark System np Nobel Biocare NobelActive NP RP No
28. e restorative instrumentation of the specified implant system This means that the clinician can expect to use the implant manufacturer s recommended drivers to engage the female connection feature of any Inclusive prosthetic component as follows Implant System Required Driver Compatible Inclusive Drivers Biomet 3i Certain 048 hex driver Not yet available 70 1071 SRG0017 Long Camlog Screw Line 050 hex driver 70 1071 SRGO0019 Short 70 1071 SRG0017 Long Dentsply Implants Astra Tech Implant System 050 hex driver 70 1071 SRG0019 Short 70 1071 SRG0017 Long 70 1071 SRG0019 Short Keystone Dental PrimaConnex Not yet available Inclusive Tapered Implant System 050 hex driver 70 1071 SRG0017 Long 70 1071 SRG0019 Short 050 hex driver Nobel Biocare Br nemark System Nobel Biocare NobelActive Unigrip driver Not yet available Nobel Biocare NobelReplace Straumann Bone Level f f f SCS Screw Carrying System driver Not yet available Straumann Tissue Level 70 1071 SRG0017 Long Zimmer Dental Screw Vent 050 hex driver 70 1071 SRGO019 Short For any system utilizing a 050 hex driver Prismatik offers a compatible handpiece driver in long and short configurations Inclusive Handpiece Hex Driver Long Inclusive Handpiece Hex Driver Short 70 1071 SRGO017 70 1071 SRGO019 800 407 3379 www glidewelldirect com 4 Torque Values Inclusive Prosthetic Components desig
29. e Black Processing Replacement Male from the metal denture cap The sharp circular edge on the end of the removal tool should be wedged tightly down into the very bottom of the Male so that it will catch the inside of the Male and pull it at an angle out of the metal housing To discard the Male from the tip on the Core Tool point the tool down and away from you and tighten the Male Removal Tool clockwise back onto the Core Tool This will activate the removal pin and dislodge the Male from the tip end of the Male Removal Tool The Locator Male Seating Tool of the Locator Core Tool 88393 is used to firmly push a Locator Replacement Male into the empty metal denture cap The Replacement Male must seat securely into place level with the rim of the cap NOTE The Replacement Male will not stay on the tool when it is turned upside down due to the varying sizes of males available It is best to hold the denture with the base side down and snap the male into the metal denture cap B Change a Locator Male 1 2 3 The Locator Core Tool 88393 which contains a Locator Male Removal Tool 88397 and Locator Male Seating Tool is used to remove the nylon male from the metal denture cap and replace it with another Locator Replacement Male Use the Locator Male Removal Tool attached to the Locator Core Tool to remove the nylon male from the metal denture cap The sharp circular edge on the end of the removal tool should be wedged tightly dow
30. e Locator Denture Cap Male In the Operatory 1 Insertion of the proper Locator Implant Abutment at tissue level must be completed see Place Locator Implant Abutment on page 42 before beginning the following impression procedure 2 Place a Locator Impression Coping with Black Processing Replacement Male 8505 onto each Locator Abutment 3 Take an impression using a firm body impression material exercising caution not to compress the soft tissue The Locator Impression Coping is designed with minimum retention to be picked up with the impression material 4 Snap a Locator Female Analog 8530 for 4 mm diameter onto each Impression Coping in the impression The Female Analog must not fall off when turned upside down with vibration NOTE An alternative reline impression technique using the patient s prosthesis is possible with use of the Locator Denture Cap Processing Male Assembly contained in package 8519 When the impression is withdrawn the Locator Denture Cap Processing Male Assembly will remain on the abutment Remove the Locator Denture Cap Processing Male Assembly from each abutment and snap it onto a Locator Female Analog Reposition this assembly back into the impression making sure it is fully seated In the Laboratory 5 Pour the master cast Upon separation the Locator Female Analog is a part of the master cast replicating the position of the Locator Implant Abutment in the oral cavity 6 Before waxing and
31. e platform specific replicas of unmodified prefabricated dental implant abutments attached to dental implant fixtures seated in the patients mouth Each abutment analog is used in a working model to represent the location and orientation of a seated implant abutment assembly and is not intended for intraoral use Prior to the casting process the appropriate analog is attached to each impression coping captured in an elastomeric impression Because each analog represents an abutment of specific dimensions mated to the restorative platform of a seated implant it is critical that the analog reflects the supragingival dimensions of the actual fixture and abutment in the oral environment Material Composition Sterility Titanium alloy Ti6AI4V Non sterile Intended Use Inclusive Abutment Analogs are to be incorporated in the production of a working model to replicate the position and orientation of implant abutment assemblies seated in the patient s mouth Contraindications Inclusive Abutment Analogs are not intended for use in the oral environment Do not use an Inclusive Abutment Analog to replicate an abutment that has been modified Abutment Analog Procedure B Select an Inclusive Abutment Analog Select the appropriate Inclusive Abutment Analog based on the system platform size and abutment height of the implant abutment assembly seated in the patient s mouth The abutment analog should match the impression cap or transfer copi
32. e reline process 800 407 3379 B www glidewelldirect com 46 2 Take a reline impression using the existing overdenture as a tray The Black Processing Replacement Males will engage the Locator Implant Abutments and hold the prosthesis in place while the impression material sets 3 When the impression is withdrawn the Black Processing Replacement Males will remain in the metal denture caps 4 Snap a Locator Female Analog 48530 for 4 mm diameter onto each Locator Denture Cap Processing Male Assembly in the impression and pour a master model 5 After processing the reline and polishing the denture base replace the Black Processing Replacement Males with the appropriate Locator Nylon Replacement Males Patient Care Good oral hygiene is vital to attachment success The Locator Implant Abutments must be thoroughly cleaned each day to prevent wear of the abutments due to buildup of abrasive plaque in the socket of the abutment The use of a soft nylon bristle or end tufted toothbrush and superfloss to polish the abutments should be taught A non abrasive gel toothpaste and an irrigation system is recommended to keep the socket of the Locator Abutment clean Patients should maintain a three to four month recall for cleaning and attachment evaluation The inside socket of the Locator Abutment and the sulcus area around the implant abutment are the primary areas of concern Use plastic instruments for scaling the abutments Do not use metal
33. ent Implants 1 Choose one of the four threads on the titanium Alignment Pin 89531 which matches the type of implant being used 2 Thread the Alignment Pin by hand directly into the divergent implant or implant analog on a stone model being careful not to cross thread the pin Place the stainless steel Angle Measurement Guide 9530 behind the Alignment Pin level with the path of prosthesis insertion to determine the divergence in degrees An additional Alignment Pin can be placed into an adjacent non divergent implant to determine the difference in the angle between it and the divergent implant WARNING If the alignment pin does not easily thread into an implant do not force the insertion NOTE An alternative method of determining the angulation of an implant is to first place the Locator abutment into the implant and then snap a Locator Parallel Post H8517 onto it Use the Angle Measurement Guide 9530 behind the Parallel Post to determine the angle of the implant 3 Choose the final Locator nylon male retention liner based upon the determined angle measurement of each implant If the divergence of an implant is less than 10 degrees use one of the Locator Replacement Males clear 5 Ibs pink 3 Ibs and blue 1 5 lbs If the divergence of any implant is between 10 degrees and 20 degrees then use one of the Extended Range Replacement Males green 4 lbs orange 2 lbs and red 1 lbs which can accommoda
34. er Selection on page 4 Insert the driver into the screw access hole to engage the female instrumentation port of the screw or guide pin 800 407 3379 B www glidewelldirect com 29 3 4 Rotate the screw or guide pin counter clockwise until completely disengaged from the internal threads of the implant analog connection cavity Carefully remove both the screw or guide pin and the restorative component as it is loosened from the implant analog platform 800 407 3379 B www glidewelldirect com 30 Inclusive Multi Unit Abutment Product Description Inclusive Multi Unit Abutments are prefabricated screw retained intraoral j abutments intended to be connected directly to endosseous implants in partially or fully edentulous patients for the retention of cast or milled bar overdentures For implant supported prostheses six or more implants are recommended in the maxilla four or more in the mandible If clinical conditions dictate fewer implants an implant retained tissue supported prostheses is indicated Multi unit abutments are precisely machined from titanium alloy and are available with a variety of collar heights to achieve optimal emergence from shallow or deep gingival wells Each Inclusive Multi Unit Abutment is delivered sterile suspended in an aseptic vial from a plastic carrier color coded to indicate the restorative platform of the seated implant Straight multi unit abutments lack any anti rotational features at the
35. ess while the open tray transfer screw should only be utilized to affix the appropriate implant analog prior to delivery to the laboratory technician IEEE mena A i Open Tray Screw Guide Pin Each open tray Inclusive Transfer Coping also comes packaged with a length of rigid plastic tubing to serve as a blockout during the impression procedure 800 407 3379 www zglidewelldirect com 11 Material Composition Sterility Titanium alloy Ti6A14V Non sterile Intended Use Inclusive Transfer Copings are prefabricated prosthetic components directly connected to endosseous dental implants for the purpose of capturing implant position in an elastomeric impression of the mandible or maxilla Contraindications Inclusive Transfer Copings should not be used for digital impressions captured with an intraoral scanner Closed Tray Impression Procedure B Select a Closed Tray Transfer Coping 1 Verify adequate primary stability of the implant before seating any Inclusive Closed Tray Transfer Coping 2 Select the appropriate Inclusive Closed Tray Transfer Coping based on the implant system platform size and impression technique to be used B Place the Closed Tray Transfer Coping 1 Ensure gingival tissue is sufficiently withdrawn from the implant access site in order to avoid pinching 2 Seat the Inclusive Closed Tray Transfer Coping onto the implant fixture so the anti rotational features of the connection engage Hand tighte
36. ide pin Each transfer coping is specific to the restorative platform of the seated implant as well as the impression technique and desired emergence profile Closed tray transfer copings are for use when employing an indirect impression technique Open tray transfer copings are for use when using a direct impression technique It is important to use the appropriate transfer coping for the impression technique employed Using a closed tray transfer coping with an open tray will result in an unreliable impression as the lack of undercuts on the closed tray coping do not impress a vertical stop for repositioning the coping without the surface of a closed tray Closed Tray Open Tray Indirect Technique Direct Technique Each closed tray Inclusive Transfer Coping comes packaged with a retaining screw Inclusive Closed Tray Transfer Screw compatible with the restorative instrumentation of the specified implant system Do not use an open tray transfer screw or guide pin with a closed tray transfer coping as the dissimilar screw lengths will allow the coping to slide along the screw shaft in an unpredictable manner ee a Closed Tray Screw Each open tray Inclusive Transfer Coping comes packaged with a retaining screw Inclusive Open Tray Transfer Screw and a provisional screw Inclusive Guide Pin compatible with the restorative instrumentation of the specified implant system The guide pin should be used throughout the impression proc
37. iently withdrawn to avoid pinching Seat an Inclusive Open Tray Multi Unit Impression Coping onto each multi unit abutment Slide the Inclusive Guide Pin provided with each Inclusive Open Tray Multi Unit Impression Coping into the impression coping Turn the guide pin clockwise to hand tighten Overtightening may result in loosening of the multi unit abutment when the guide pin is removed Follow documentation for the chosen impression material to take a full arch elastomeric impression Once the impression material has set within the open tray unscrew and remove the guide pin with the tray still in place on the arch Remove the tray from the patient s ridge The open tray multi unit impression copings should be captured by the impression material 800 407 3379 B www glidewelldirect com 34 7 8 Mount an Inclusive Multi Unit Abutment Analog onto each open tray multi unit impression coping captured within the impression and refasten using the guide pin Proceed with the fabrication of a stone model using standard laboratory techniques Upon separation the multi unit abutment analogs are a part of the master cast replicating the position of each multi unit abutment in the oral cavity Temporize with Multi Unit Abutments 1 2 3 4 5 6 7 Seat an Inclusive Multi Unit Titanium Temporary onto each multi unit abutment and hand tighten the Inclusive Prosthetic Screw provided using the appropriate driver see
38. irect technique ensure that the Inclusive Closed Tray Multi Unit Impression Copings are placed appropriately within the elastomeric impression Ensure each captured closed tray multi unit impression coping is fitted with a fully seated Inclusive Multi Unit Abutment Analog and that there is no lateral movement of the analog If movement is observed a new impression is required Follow pouring procedures for the appropriate die stone to produce a working model It is highly recommended that a soft tissue model be fabricated by syringing soft tissue material around the analog coping interface prior to pouring the die stone For impressions captured with the open tray direct technique unscrew and remove the guide pin from the underside of the impression tray before separating the model from the impression 800 407 3379 B www glidewelldirect com 35 B Laboratory Create the Verification Index 1 2 3 4 5 6 Seat an Inclusive Multi Unit Gold Plastic Coping onto each analog captured in the stone working model and hand tighten with an Inclusive Guide Pin using the appropriate driver Remove the plastic sleeve from each coping by pulling straight up on the sleeve Lute two adjacent copings together at the non tapered coronal aspect with light cure composite resin or autopolymerizing acrylic resin Once cured separate the resin connections with a high speed disc bur or Bard Parker knife Repeat for each pair of adjacen
39. ls for sterility classification Products labeled sTERILE are intended for single use only prior to the expiration date printed on the product label Do not use sterile products if the packaging has been compromised or previously opened Do not re sterilize or autoclave except where instructions to do so are provided for that product by the manufacturer Inclusive Prosthetic Components labeled NON STERILE should be cleaned disinfected and sterilized according to a validated method prior to use in the oral environment The recommended disinfection process is based on ANSI AAMI ST79 guidelines as follows Immerse abutments in disinfectant rinse with distilled water and dry The recommended sterilization process is based on the ANSI AAMI ISO 17665 1 and ANSI AAMI ST79 guidelines as follows Gravity fed sterilizers Autoclave in sterilization pouch for thirty 30 minutes at 121 C 250 F Allow sterilized components to completely dry Refer to the disinfectant manufacturer s instructions 7ANSI AAMI ST79 NOTE The validated procedures require the use of FDA cleared sterilization trays wraps biological indicators chemical indicators and other sterilization accessories labeled for the sterilization cycle recommended The healthcare facility should monitor the sterilizer for the facility according to an FDA recognized sterility assurance standard such as ANSI AAMI ST79 800 407 3379 B www glidewelldirect com 2 Storage and Han
40. move the prosthetic screws and return the bar to the laboratory for fabrication of the final prosthesis If a passive fit is not achieved 4 Determine the two connection points between which the bar ceases to fit passively 5 Remove the prosthetic screws and remove the bar from the patient s mouth 6 Using a high speed disc bur cut through the bar at the point where the bar ceases to fit passively 7 Reseatthe bar sections into the patient s mouth and hand tighten with prosthetic screws 8 Apply autopolymerizing resin liberally to the separation point between the sections and allow to set in the new configuration 9 Remove and return the modified bar to the lab for fabrication B Laboratory Prepare the Final Prosthesis for Bar Retention Follow procedures to process and finish the denture with the chosen bar attachments integrated B Deliver the Final Restoration 1 Remove any temporary prosthesis 2 Confirm that each multi unit abutment is tightened to the implant manufacturer s recommended torque value see Torque Values on page 5 For screw retained fixed removable prosthesis 3 Line the prosthesis onto the abutments Beginning with the midmost screw access channel hand tighten an Inclusive Prosthetic Screw into the multi unit abutment Repeat for each abutment working outward and alternating left to right 4 Confirm appropriate seating With the same middle out left to right technique tighten each pro
41. mposite and cure Otherwise follow applicable cementation procedures to affix the definitive restoration to the abutment 800 407 3379 B www glidewelldirect com 21 Inclusive Titanium Esthetic Abutment Product Description Inclusive Titanium Esthetic Abutments are prefabricated screw retained intraoral abutments intended to be connected directly to an endosseous implant for retention of a cemented dental prosthesis They may be indicated for single and multiple tooth restorations Titanium esthetic abutments are precisely machined from titanium alloy and attached to the implant fixture with a titanium screw Unlike the circular emergence profile of standard stock abutments esthetic abutments are manufactured with a tapered emergence profile for more natural looking contouring of the soft tissue at the implant site Each esthetic abutment is specific to the restorative platform of the seated implant and anatomically designed for the connection site s region on the ridge anterior or posterior In addition to the standard straight abutment body angled abutment bodies produced with a 15 degree slope of one hemisphere to compensate for an undesirable path of insertion resulting from excessive implant angulation are available 1 15 Angle Straight 15 Angle Straight Posterior Posterior Anterior Anterior Each Inclusive Titanium Esthetic Abutment is packaged with a separate retaining screw Inclusive Titani
42. n into place using the Inclusive Closed Tray Transfer Coping Screw provided NOTE It is recommended that a radiograph be taken of the implant coping connection to confirm the transfer coping is completely seated before proceeding B Capture the Impression 1 Follow documentation for the chosen impression material to take a full arch elastomeric impression 2 Once the impression material has set within the closed tray remove the tray from the patient s ridge The Inclusive Closed Tray Transfer Coping will remain connected to the seated implant 800 407 3379 B www glidewelldirect com 12 E Record Implant Placement 1 Unscrew the Inclusive Closed Tray Transfer Coping from the seated implant and remove Mount a corresponding implant analog on the closed tray transfer coping and fasten with the same closed tray transfer coping screw 2 Reposition the closed tray transfer coping into its corresponding depression in the impression tray and press firmly to engage The implant analog should protrude from the impression 3 Proceed with the fabrication of a stone model using standard laboratory techniques Upon separation the implant analog is a part of the master cast replicating the position of the implant seated in the oral cavity Open Tray Impression Procedure B Select an Open Tray Transfer Coping 1 Verify adequate primary stability of the implant before seating any Inclusive Open Tray Transfer Coping 2 Select the app
43. n into the very bottom of the Male so that it will catch the inside of the Male and pull it at an angle out of the metal housing To discard the nylon male from the tip on the Core Tool point the tool down and away from you and tighten the Male Removal Tool clockwise back onto the Core Tool This will activate the removal pin and dislodge the Male from the tip end of the Male Removal Tool The Male Seating Tool is used to firmly push a Locator Replacement Male into the empty metal denture cap The Replacement Male must seat securely into place level with the rim of the cap Use of multiple Locator attachments three or more in the same dental arch may require use of the 1 5 pound extra light retention blue colored Replacement Male 8529 in combination with 0 0 pound non retentive gray colored Replacement Male 48558 for easier removal of the prosthesis by the patient NOTE The Replacement Male will not stay on the tool when it is turned upside down due to the varying sizes of males available It is best to hold the denture with the base side down and snap the male into the metal denture cap B Reline and Rebase 1 Remove each existing nylon male from its metal denture cap following the steps in Change a Locator Male on page 46 Replace them with Black Processing Replacement Males 88515 The built in spacer of the Black Processing Replacement Male will maintain the overdenture in its upper level of vertical resiliency during th
44. n of the platform specific base Polish as necessary Finish the UCLA Restoration Follow procedures for the final restoration material to bond the restorative layers to the custom abutment 800 407 3379 B www glidewelldirect com 27 Inclusive Titanium Screw Guide Pin Product Description Inclusive Titanium Screws and Inclusive Guide Pins are threaded fasteners used to attach implant prosthetic components to dental implant fixtures or implant analogs on a temporary or long term basis Each screw or guide pin is precisely machined from titanium alloy and is specific to the system or the restorative platform of the seated implant The occlusal surface of the screw or guide pin contains a female instrumentation port compatible with the restorative driver recommended by the implant manufacturer Titanium screws are generally reserved for the long term retention of a finished provisional or definitive restoration in the oral environment A screw used to attach prosthetic components to an implant analog in a working model during laboratory fabrication processes should be replaced with a new screw upon final delivery of the definitive restoration Guide pins are reserved for provisional applications to attach prosthetic components to an implant analog captured in a working model during laboratory fabrication processes or after sterilization to attach an Inclusive Open Tray Transfer Coping to an endosseous dental implant during an open t
45. nd outside retention ensures the longest lasting performance Rotational Pivoting Action The design of the pivoting Locator Male allows a resilient connection for the prosthesis without any resulting loss of retention The retentive nylon male remains completely in contact with the abutment socket while its titanium denture cap has a full range of rotational movement over the male Use With Non Parallel Implants The Locator Replacement Males can be used to restore an implant with up to 10 degrees of divergence 20 degrees between implants The Locator Extended Range Replacement Males can accommodate a divergent implant between 10 and 20 degrees 40 degrees between implants Restorative Procedure with Locator Abutments B Place Locator Implant Abutment 1 Toselect the proper Locator Implant Abutment determine the type of implant and the diameter being used Then measure the tissue thickness from the apical rim of the implant body to the crest of the gingiva at the highest side of the implant site Choose the corresponding abutment tissue cuff height that exactly equals the tissue measurement or is the next closest higher size available The exact tissue cuff height of Locator abutment will position the proper 1 5 mm of working attachment above the surrounding gingival level which should not be submerged below the tissue 2 After the secondary gingival healing period is complete remove the healing cuff according to instructions provided b
46. ned to support a provisional or final prosthesis should be affixed to the implant and tightened using a properly metered torque wrench to the value recommended by the implant manufacturer as indicated in the table below The application of torque in excess of the manufacturer s recommended value may result in fracture of the implant fixture or retaining screw Insufficient application of torque may result in screw loosening or inadequate component attachment Implant System Manufacturer s Recommended Torque Ncm Abutment Abutment Screw Abutment Screw Prosthetic Screw Biomet 3i Certain 3 4 mm 4 1 mm 5 0 mm 6 0 mm 15 Ncm 20 Ncm 20 Ncm 15 Nom Camlog Screw Line 3 3 mm 3 8 mm 4 3 mm 5 0 mm 6 0 mm 15 Ncm 20 Ncm 20 Ncm 15 Ncm Dentsply Implants Astra Tech Implant System X Small 2 5 mm Small 2 9 mm 20 Ncm 15 Ncm Large 3 9 mm 25 Ncm 15 Ncm Inclusive Tapered Implant System 3 5 mm 4 5 mm 15 Ncm 35 Ncm 30 Ncm 15 Ncm Nobel Biocare Br nemark System RP 3 75 mm 15 Ncm 35 Ncm 35 Ncm 15 Ncm Nobel Biocare NobelActive NP 3 5 mm RP 4 3 mm 15 Ncm 35 Ncm 35 Ncm 15 Ncm Nobel Biocare NobelReplace NP RP WP 6 0 15 Ncm 35 Ncm 35 Ncm 15 Ncm Straumann Bone Level NC RC 15 Ncm 35 Ncm 35 Ncm 15 Ncm Straumann Tissue Level NN 15 Ncm 15 Ncm RN synOcta WN synOcta 15 Ncm 35 Ncm Zimmer Dental Screw Vent 3 5 mm 4 5 mm 5 7 mm 15 Ncm 30 Ncm 30 Ncm 15 Ncm indicates product not available Any screw retained
47. ng captured in the elastomeric impression E Attach the Abutment Analog 1 Align the flat side of the Inclusive Abutment Analog with the flat side of the positioning cylinder captured in the impression 2 Insert the abutment analog into the impression until it snaps securely into place as indicated by an audible click Verify that the analog is flush against the transfer coping or impression cap 800 407 3379 B www glidewelldirect com 18 3 Proceed with the fabrication of a stone model using standard laboratory techniques Upon separation the abutment analog is a part of the master cast replicating the position of the implant abutment assembly seated in the oral cavity 800 407 3379 B www glidewelldirect com 19 Inclusive Titanium Abutment Product Description Inclusive Titanium Abutments are prefabricated screw retained intraoral abutments intended to be connected directly to an endosseous implant for retention of a cemented dental prosthesis They may be indicated for single and multiple tooth restorations Titanium abutments are precisely machined from titanium alloy and attached to the implant fixture with a titanium screw For use in any region of the mouth they contain a standard circular emergence profile and straight abutment body available in 3 mm 4 5 mm and 6 mm vertical height options Each abutment is specific to the restorative platform of the seated implant 3 mmH 4 5 mmH 6 mmH Each Inclusive Titanium Abutme
48. not tighten using torque instruments Each scanning abutment is specific to the restorative platform of the seated implant Inclusive Scanning Abutment E Product Description Clinical Scanning Abutments containing a radiopaque barium sulfate material are designed for chairside use with intraoral scanners Connected to the original implant body their opacity on a radiograph allows accurate confirmation of complete seating Smaller heights are available to accommodate ease of attachment in the posterior arch Placed intraorally attached to an implant in a patient s mouth Inclusive Scanning Abutments are intended for single use only Multiple use in a clinical setting is contraindicated due to potential scan inaccuracies and the risk of cross contamination Laboratory Scanning Abutments produced from radiolucent material are designed to be used with implant analogs on a stone model They may also be used chairside but may be difficult to observe radiographically Used in the laboratory attached to an implant analog in a working cast Inclusive Scanning Abutments may be considered multiple use devices Inspect each scanning abutment prior to use Do not use a scanning abutment that is damaged or unclean E f T Clinical Scanning Laboratory Scanning Abutment Abutment Material Composition Sterility Polyether ether ketone PEEK Non sterile Titanium alloy TiGAlAV Intended Use Inclusive Scanning Abutments are to be use
49. nt into the seated implant or implant analog Ensure that the scanning abutment is fully seated without excessive vertical or rotational play Excessive play indicates an incorrectly seated scanning abutment Reposition before tightening the screw 4 Hand tighten the scanning abutment using the appropriate driver Do not overtighten B Capture the Digital Scan Follow manufacturer instructions for the intraoral scanner to capture the digital impression B Remove the Scanning Abutment 1 Using the appropriate driver loosen the captured screw until fully disengaged from the body of the implant or implant analog 2 Removethe Inclusive Scanning Abutment from the implant interface 3 If used intraorally discard the scanning abutment If used in a laboratory setting the scanning abutment may be stored in a clean protected environment for future laboratory use 800 407 3379 B www glidewelldirect com 16 Inclusive Implant Analog Product Description Inclusive Implant Analogs are platform specific replicas of dental implant fixtures used in a working model to represent the location and platform orientation of a seated implant They are not intended for intraoral use Prior to the casting process the appropriate analog is attached to each impression coping captured in an elastomeric impression Because each analog is specific to the restorative platform of the seated implant it is critical that the analog platform matches that of the
50. nt is packaged with a separate retaining screw Inclusive Titanium Screw compatible with the restorative instrumentation of the specified implant system Titanium Screw Material Composition Sterility Titanium alloy Ti6A14V Non sterile Intended Use Inclusive Titanium Abutments are prefabricated prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation Contraindications The following conditions would contraindicate use of Inclusive Titanium Abutments Wall thickness less than 0 5 mm Gingival margin diameter less than 0 5 mm wider than the implant Angle corrections of more than 20 degrees Less than 0 5 mm margin height Less than 4 0 mm abutment height 800 407 3379 B www glidewelldirect com 20 Restorative Procedure with Titanium Abutments B Capture Implant Placement Take an implant level impression utilizing the preferred technique direct indirect or intraoral scan Submit the impression to the laboratory B Laboratory Fabricate the Restoration 1 2 3 4 5 Follow pouring procedures for the appropriate die stone to produce a working model and articulate with a bite registration Select the appropriate Inclusive Titanium Abutment based on the system platform size location and occlusal clearance of the implant seated in the patient s mouth Seat the abutment completely into the implant analog
51. ntal devices produced using said product User is responsible for determining the suitability of the product for user s application If this product is defective within the warranty period user s exclusive remedy and Glidewell s sole obligation shall be replacement or refund of the purchase price of the product For replacement or refund under this warranty the original purchaser shall send the product at its own expense postage prepaid to Glidewell Direct 18651 Von Karman Ave Irvine CA 92612 800 407 3379 B www glidewelldirect com 48 INCLUSIVE PROSTHETIC COMPONENTS Designed amp Manufactured in the USA by PRISMATIK DENTALCRAFT INC A wholly owned subsidiary of Glidewell Laboratories 2212 Dupont Dr e Irvine CA 92612 Distributed by GLIDEWELL DIRECT CLINICAL AND LABORATORY PRODUCTS 18651 Von Karman Ave Irvine CA 92612 To Order Call 800 407 3379 Online www glidewelldirect com 3021302_1 0 ECO 3021301 GD 852 040414
52. ocedure for Multi Unit Abutments 1 2 3 4 5 6 7 Ensure gingival tissue is sufficiently withdrawn to avoid pinching Twist an Inclusive Closed Tray Multi Unit Impression Coping onto each multi unit abutment until fully seated Hand tighten only Overtightening may result in loosening of the multi unit abutments when the copings are removed Follow documentation for the chosen impression material to take a full arch elastomeric impression Once the impression material has set within the closed tray remove the tray from the patient s ridge Each closed tray multi unit impression coping will remain connected to its corresponding abutment Unscrew each closed tray multi unit impression coping from its corresponding multi unit abutment and remove Twist each closed tray impression coping onto an Inclusive Multi Unit Abutment Analog and hand tighten Reposition each closed tray multi unit impression coping into its corresponding depression in the impression tray and press firmly to engage The multi unit abutment analogs should protrude from the impression Proceed with the fabrication of a stone model using standard laboratory techniques Upon separation the multi unit abutment analogs are a part of the master cast replicating the position of each multi unit abutment in the oral cavity Open Tray Direct Impression Procedure for Multi Unit Abutments 1 2 3 4 5 6 Ensure gingival tissue is suffic
53. of the connection interface are engaged Lift and rotate as necessary to orient the angle in the required direction 4 Hand tighten the Inclusive Angled Multi Unit Abutment Screw using the appropriate driver see Driver Selection on page 4 Twist the plastic carrier counterclockwise to remove It is strongly recommended that a radiograph of the connection site be taken to confirm complete seating of the abutment before proceeding 5 Using the appropriate driver in conjunction with a properly metered torque wrench tighten the multi unit abutment to the implant manufacturer s recommended torque value see Torque Values on page 5 B Delayed Loading of Multi Unit Abutments 1 If the initial stability of the seated implant is insufficient for loading cover each Inclusive Multi Unit Abutment with an Inclusive Multi Unit Temporary Healing Cap and hand tighten with the Inclusive Prosthetic Screw provided using the appropriate driver Do not overtighten 2 Using the patient s existing denture or other prosthesis relieve the area directly above the placement of each temporary healing cap until the denture rests on the ridge 800 407 3379 B www glidewelldirect com 33 3 Follow procedures to reline the denture over the temporary healing caps using soft reline material only The temporized denture can be used during a healing phase until the implants obtain sufficient load bearing stability Closed Tray Indirect Impression Pr
54. on A non engaging UCLA is indicated for multi unit bridges to allow passive path of insertion without anti rotational restrictions UL Plastic UCLA Plastic UCLA Engaging Non Engaging Each Inclusive UCLA is packaged with a separate provisional screw Inclusive Guide Pin and separate retaining screw Inclusive Titanium Screw compatible with the restorative instrumentation of the specified implant system The guide pin should be used throughout the fabrication process The titanium screw should only be utilized to retain the finished provisional r I Guide Pin Titanium Screw Material Composition Sterility Polymers acetal copolymer Non sterile Titanium alloy TiGAlAV 800 407 3379 B www glidewelldirect com 25 Intended Use Inclusive Universal Clearance Limited Abutments UCLA are prefabricated prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation Contraindications The following conditions would contraindicate use of Inclusive Universal Clearance Limited Abutments Wall thickness less than 0 5 mm Gingival margin diameter less than 0 5 mm wider than the implant Angle corrections of more than 20 degrees Less than 0 5 mm margin height Less than 4 0 mm abutment height Angled abutments should not be used to restore small diameter implants less than or equal to 3 0 mm in the posterior region Casting C
55. on the working model making sure that the anti rotational features of the connection interface are fully engaged Insert the Inclusive Titanium Screw provided into the abutment s screw access hole and hand tighten using the appropriate driver Fabricate the restoration using conventional casting or CAD CAM techniques Veneer as necessary If a screw retained hybrid restoration is indicated lute the ceramic crown to the titanium abutment B Deliver the Final Restoration 1 2 3 4 5 Seat the titanium abutment or screw retained hybrid restoration completely into the implant making sure that the anti rotational features of the connection interface are fully engaged and the contours of the sculpted emergence profile are esthetically oriented Insert the Inclusive Titanium Screw provided into the screw access hole and hand tighten using the appropriate driver It is strongly recommended that a radiograph of the connection site be taken to confirm complete seating of the abutment or hybrid restoration before proceeding Using the appropriate driver in conjunction with a properly metered torque wrench tighten the abutment or hybrid restoration to the implant manufacturer s recommended torque value see Torque Values on page 5 Fill the screw access hole with cotton Teflon tape gutta percha or other suitable material If the restoration is of a screw retained hybrid design cover the screw access hole with flowable co
56. onent against the implant fixture or implant analog to which it will be attached Insert the Inclusive Titanium Screw or Inclusive Guide Pin through the screw access hole of the restorative component and into the internal connection cavity of the implant fixture or implant analog Make sure the screw or guide pin enters at the same angle as the implant or analog to avoid potential damage that may result from cross threading Rotate the screw or guide pin clockwise until engaged with the internal threads of the implant analog connection cavity Select the appropriate driver based on the implant system being utilized see Driver Selection on page 4 Using the selected driver in conjunction with a properly metered torque wrench advance threaded delivery of the screw or guide pin until the restorative component is fully seated against the implant analog platform Hand tighten only if indicated Otherwise tighten to the implant manufacturer s recommended torque value see Torque Values on page 5 Verify complete seating of the restorative component against the implant analog platform Utilize radiography to do so if clinically appropriate Retrieval Procedure B Detach the Restorative Component 1 2 If applicable remove any overlying restoration or other material preventing access to the head of the Inclusive Titanium Screw or Inclusive Guide Pin Select the appropriate driver based on the implant system being utilized see Driv
57. onent that is damaged or unclean Components and accessories used intraorally should be secured to prevent aspiration or ingestion Following successful implant placement verify primary stability before proceeding with the delivery of a permanent or provisional prosthesis The healing period varies depending on the quality of the bone at the implantation site the tissue response to the implanted fixture and the surgeon s evaluation of the patient s bone density at the time of the surgical procedure Distribution of stress is an important consideration Particular care should be taken to avoid the application of force on the dental implant during the healing period Post healing care should still be taken to avoid excessive loads significantly transverse to the implant axes In addition proper occlusion should be evaluated on the provisional or definitive implant restoration to avoid excessive force during everyday function Due to the high thermal conductivity of titanium prefabricated titanium abutments should not be modified in the oral cavity Any necessary modifications should be made extraorally by attaching the abutment to an implant analog retained by an analog holder or captured in a working model Modify with a fine diamond or carbide bur MRI Inclusive Prosthetic Components have not been evaluated for safety compatibility heating or migration in the magnetic resonance MR environment Sterility Refer to individual product labe
58. opriate driver in conjunction with a properly metered torque wrench tighten the abutment or hybrid restoration to the implant manufacturer s recommended torque value see Torque Values on page 5 800 407 3379 B www glidewelldirect com 23 4 5 Fill the screw access hole with cotton Teflon tape gutta percha or other suitable material Follow applicable cementation procedures to affix the definitive restoration to the abutment Or if the restoration is of a screw retained hybrid design cover the screw access hole with flowable composite and cure 800 407 3379 B www glidewelldirect com 24 Inclusive UCLA Abutment Product Description Inclusive Universal Clearance Limited Abutments UCLAs are indicated for laboratory use to manually create an implant level custom abutment for a cement or screw retained restoration UCLA abutments are precisely machined from acetal copolymer and attached to the implant fixture or implant analog with a titanium screw or provisional guide pin A plastic sleeve mounted to the abutment provides a castable pattern on which to wax a custom abutment Each UCLA is specific to the restorative platform of the seated implant Plastic UCLAs will burn out completely during the casting process to create a monolithic abutment For most implant systems they are available with an engaging or non engaging connection interface Engaging UCLAs are indicated for single unit restorations to prevent rotati
59. plant analog Using the Inclusive Guide Pin packaged with the Inclusive Temporary Abutment or Inclusive Bite Verification Cylinder hand tighten the abutment into place against the implant or implant analog Block out any undercuts on adjacent teeth Failure to do so may result in the provisional becoming locked in during reline Prepare the provisional crown or bridge form by drilling a hole through the mold directly above the seated implant or implant analog E Fabricate the Provisional Restoration 1 2 3 4 Fill the plastic crown or bridge form with composite resin acrylic or other temporary crown and bridge material Care must be taken to confine temporary crown and bridge material to the restoration space only Place the plastic mold onto the ridge or model The guide pin should protrude through the hole previously drilled into the mold Apply vertical pressure to the mold and confirm that it is firmly seated on all guide teeth While maintaining pressure follow curing procedures for the chosen crown and bridge material Once the crown and bridge material is properly cured remove the screw 800 407 3379 B www glidewelldirect com 9 5 Remove the mold and provisional restoration from the ridge together The Inclusive Temporary Abutments or Inclusive Bite Verification Cylinders should be captured within the restoration 6 Remove the restoration from the mold and make adjustments as needed Place the Provi
60. ponent and restorative cost of treatment while maintaining the highest standard of quality Having assembled a diverse team of experts with decades of combined experience in the design engineering and manufacture of dental implants along with a staff of highly respected researchers material scientists clinical specialists restorative doctors and dental technicians we at Prismatik are dedicated to advancing implant dentistry by combining proven treatment protocols with cutting edge materials technologies and techniques Prosthetic components for the Inclusive Tapered Implant System include a wide array of esthetic and multi unit titanium abutments along with analogs screws temporary and UCLA abutments digital and conventional transfer copings and more Prismatik Dentalcraft also has FDA 510 k clearance for prosthetic connections that are compatible with several of the industry s other leading implant manufacturers Prosthetic components manufactured by Prismatik Dentalcraft are produced in an ISO 13485 certified environment in Irvine California operating under U S Food and Drug Administration Current Good Manufacturing Practices CGMPs This ensures tight tolerances precision machining state of the art processing and cleaning and extensive validation testing from fatigue strength assessment to packaging integrity analysis Uniform component costs across systems allow for predictable pricing The result is a product that offers imme
61. porary screw retained restorations Provisional restorations can be made chairside using any standard fabrication technique e g vacuum formed sheet prefabricated crown bridge form etc Temporary abutments and bite verification cylinders are precisely machined from titanium alloy and attached to the implant fixture or implant analog by a titanium screw or provisional guide pin Each temporary abutment or bite verification cylinder is specific to the restorative platform of the seated implant Engaging temporary abutments are indicated for single unit restorations to prevent rotation of the provisional crown Non engaging temporary abutments are indicated for multi unit bridges and therefore avoid the unnecessary anti rotational implant connection feature to allow for a passive path of insertion gt ca Engaging Non Engaging Each Inclusive Temporary Abutment or Inclusive Bite Verification Cylinder is packaged with a separate provisional screw Inclusive Guide Pin and separate retaining screw Inclusive Titanium Screw compatible with the restorative instrumentation of the specified implant system The guide pin should be used throughout the fabrication process The titanium screw should only be utilized to retain the finished provisional 2ooQ UU Guide Pin Titanium Screw Material Composition Sterility Titanium alloy Ti6Al4V Non sterile Intended Use Inclusive Temporary Abutments and Inclusive Bite Ve
62. ray direct impression procedure Titanium Screw Guide Pin retaining screw provisional screw Material Composition Sterility Titanium alloy TiGAlAV Non sterile Intended Use Inclusive Titanium Screws are indicated for the temporary or long term retention of implant restorative components to an endosseous dental implant fixture seated in the oral environment or to an implant analog Inclusive Guide Pins are indicated for the temporary retention of implant restorative components to an implant analog or to temporarily attach an Inclusive Open Tray Transfer Coping to an endosseous dental implant during an open tray direct impression procedure 800 407 3379 B www glidewelldirect com 28 Contraindications Inclusive Guide Pins are not intended for use in the oral environment except to temporarily attach an Inclusive Open Tray Transfer Coping to an endosseous dental implant during an open tray direct impression procedure Attachment Procedure B Select a Screw or Guide Pin Select the appropriate Inclusive Titanium Screw or Inclusive Guide Pin based on the intended application as well as the system of the implant or implant analog to which the restorative component will be attached For implant systems that utilize platform specific screws consideration must also be given to the size of the restorative platform B Attach the Restorative Component 1 2 3 4 5 Properly seat the restorative comp
63. rification Cylinders are prefabricated prosthetic components directly connected to endosseous dental implants They are intended for use to support single or multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing or for fabrication of try in prostheses 800 407 3379 B www glidewelldirect com 8 Contraindications Inclusive Temporary Abutments and Inclusive Bite Verification Cylinders are not intended for applications exceeding 180 days during endosseous and gingival healing Temporary Abutment Placement Procedure B Select a Temporary Abutment or Bite Verification Cylinder 1 2 Verify adequate primary stability of the implant before seating any Inclusive Temporary Abutment or Inclusive Bite Verification Cylinder Select the appropriate Inclusive Temporary Abutment or Inclusive Bite Verification Cylinder based on the implant system platform size and type of provisional restoration to be fabricated B Place the Temporary Abutment or Bite Verification Cylinder 1 2 3 4 5 Modify the Inclusive Temporary Abutment or Inclusive Bite Verification Cylinder as needed prior to seating Seat the base of the Inclusive Temporary Abutment against the exposed implant platform or implant analog if the provisional is being fabricated on a model If engaging align the anti rotational connection feature of the abutment with the internal cavity of the seated implant or im
64. ropriate Inclusive Open Tray Transfer Coping based on the implant system platform size and impression technique to be used B Place the Open Tray Transfer Coping 1 Ensure gingival tissue is sufficiently withdrawn from the implant access site in order to avoid pinching 2 Seat the Inclusive Open Tray Transfer Coping onto the implant fixture so the anti rotational features of the connection engage Hand tighten into place using the Inclusive Guide Pin provided 3 Slide the blockout tube provided over the guide pin making sure it rests firmly on the occlusal end of the open tray transfer coping B Prepare the Impression Tray Using a custom tray prepare a hole in the tray that will align with the Inclusive Open Tray Transfer Coping and the protruding Inclusive Guide Pin when the impression is taken NOTE It is recommended that a radiograph be taken of the implant coping connection site to confirm the transfer coping is completely seated before proceeding B Capture the Impression 1 Follow documentation for the chosen impression material to take a full arch elastomeric impression 2 Oncethe impression material has set within the open tray remove the blockout tube to expose the protruding guide pin 800 407 3379 B www glidewelldirect com 13 3 4 With the tray still in place on the ridge unscrew and remove the guide pin from the Inclusive Open Tray Transfer Coping Remove the tray from the patient s ridge
65. sional Restoration 1 Reseat the provisional restoration onto the ridge Utilize radiography to verify complete seating if clinically appropriate 2 Locate the Inclusive Titanium Screw that came packaged with the Inclusive Temporary Abutment or Inclusive Bite Verification Cylinder 3 Select the appropriate driver based on the implant system being utilized see Driver Selection on page 4 Using the selected driver advance threaded delivery of the titanium screw until fully seated in order to secure the temporary abutment or bite verification cylinder to the implant 4 Using the appropriate torque wrench tighten the titanium screw to the implant manufacturer s recommended value for a temporary restoration see Torque Values on page 5 5 Fill the screw access hole with cotton Teflon tape gutta percha or other suitable material 6 Sealthe screw access hole with temporary veneering material 800 407 3379 B www glidewelldirect com 10 Inclusive Transfer Coping Product Description Inclusive Transfer Copings are used to transmit the position angulation and connection feature orientation of seated implants when captured in an elastomeric impression Impressions may be taken with either the indirect or direct technique depending on the clinician s preference and chairside conditions Transfer copings are precisely machined from titanium alloy and attached to the implant fixture by a titanium screw or gu
66. sthetic screw to 15 Ncm 5 Check comfort and occlusion and make any necessary adjustments 6 Fill each screw access channel with gutta percha silicone or other suitable temporary material 800 407 3379 B www glidewelldirect com 39 For attachment retained removable prosthesis 3 Follow procedures to seat the attachment component onto each multi unit abutment Tighten to the manufacturer s recommended torque value see Torque Values on page 5 4 Line the prosthesis onto the attachment components and snap into place Check comfort and occlusion and make any necessary adjustments 800 407 3379 B www glidewelldirect com 40 LOCATOR Abutment Intended Use The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla Contraindications Not appropriate where a totally rigid connection is required Use on a single implant with divergence of greater than 20 degrees is not recommended Caution U S federal law restricts this device to sale by or on the order of a licensed dentist or physician Single Use Devices Locator Males The inadvertent re use of Locator nylon males could cause loss of retention for the overdenture due to wear from previous use or damage during removal with the Locator Core Tool Locator Abutments The inadvertent re use of Locator abutments could contain patient contamination
67. stomeric bite registration material onto the rim and create the bite registration 7 Remove the occlusal rim from the patient s mouth Replace and fasten to the working cast with the guide pins and return the working cast occlusal rims and bite registration to the laboratory B Laboratory Fabricate the Wax Try In With the record base articulated via the interocclusal record follow procedures to mount the wax try in denture teeth onto the stabilized record base B Try in the Restoration 1 Seat the wax try in onto the multi unit abutments on the patient s ridge and hand tighten with the prosthetic screws 2 Modify as needed to obtain the desired esthetics phonetics and occlusion 3 Remove the wax try in and return the approved apparatus to the laboratory B Laboratory Fabricate the Final Prosthesis 1 Follow plaster or silicone casting procedures to fabricate a matrix of the approved wax try in 2 Using the wax try in as the template follow procedures to create the final prosthesis If the prosthesis will be bar retained the bar should be fabricated concurrently with the prosthesis to ensure proper fit and adequate retention B Laboratory Fabricate a Retention Bar Fabricate a retention bar for the prosthesis according to the desired method Specific procedures for fabricating a cast bar an immediate bar and a CAD CAM bar are outlined separately below 800 407 3379 B www glidewelldirect com 37 B Laboratory
68. t copings Once all copings are sectioned confirm all guide pins are hand tightened and lute all sections together by adding a small amount of resin to each separation point Remove the guide pins and the verification index Send the verification index and the prosthetic screws included with the Multi Unit Gold Plastic Copings to the restorative dentist E Confirm a Passive Fit with the Verification Index 1 2 3 4 Place the verification index on the multi unit abutments Hand tighten either of the distal most copings into the multi unit abutment using a prosthetic screw and the appropriate driver Confirm that the remaining copings sit passively and completely on their respective abutments Fasten each of the remaining copings beginning with the distal and working forward by alternating sides Hand tighten only If a passive fit is achieved an accurate transfer has been recorded Remove the verification index B Laboratory Fabricate a Record Base and Occlusal Rim 1 2 3 4 Re attach the verification index to the working model with a hand tightened Inclusive Guide Pin for each coping The verification index will act as the framework for the record base Follow instructions for the record base material to form and cure the base around the index framework Be sure the material conforms fully to the contours of the edentulous arch The base should fit tightly around the protruding guide pins and fill in an
69. te a divergent implant up to 20 degrees 40 degrees between implants Locator Replacement Males Extended Range Replacement Males Clear 5 0 lbs Pink 3 0 Ibs Blue 1 5 Ibs Green 4 0 Ibs Orange 2 0 Ibs Red 1 0 Ibs 8524 Light Retention Extra Light 8547 8915 Extra Light 8527 Retention Retention 8529 8548 4 Follow the steps in the section entitled Clinical Placement of the Locator Denture Cap Male for chairside placement of the Locator Male or the steps in the section entitled Laboratory Placement of the Locator Denture Cap Male for indirect placement of the Locator Male B Clinical Placement of the Locator Denture Cap Male 1 Insertion of the proper Locator Implant Abutment at tissue level must be completed see Place Locator Implant Abutment on page 42 before beginning the procedure for placement of the Locator Denture Cap Processing Male Assembly 800 407 3379 B www glidewelldirect com 43 2 3 4 5 6 7 8 9 Place a White Block Out Spacer contained in package 48519 over the head of each Locator Abutment The spacer is used to block out the area immediately surrounding the abutment The space created will allow the full resilient function of the pivoting metal denture cap over the Locator Black Processing Replacement Male NOTE If the White Block Out Spacer does not completely fill the space between the tissue and the metal denture cap it is necessary to block out any
70. um Screw compatible with the restorative instrumentation of the specified implant system Titanium Screw Material Composition Sterility Titanium alloy Ti6A14V Non sterile Intended Use Inclusive Titanium Esthetic Abutments are prefabricated prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation Contraindications The following conditions would contraindicate use of Inclusive Titanium Esthetic Abutments Wall thickness less than 0 5 mm Gingival margin diameter less than 0 5 mm wider than the implant 800 407 3379 B www glidewelldirect com 22 Angle corrections of more than 20 degrees Less than 0 5 mm margin height Less than 4 0 mm abutment height Angled abutments should not be used to restore small diameter implants less than or equal to 3 0 mm in the posterior region Restorative Procedure with Titanium Esthetic Abutments B Capture Implant Placement Take an implant level impression utilizing the preferred technique direct indirect or intraoral scan Submit the impression to the laboratory B Laboratory Fabricate the Restoration 1 2 3 4 5 Follow pouring procedures for the appropriate die stone to produce a working model and articulate with a bite registration Select the appropriate Inclusive Titanium Esthetic Abutment based on the system platform size location angulation and occlusal clearance
71. ustom Abutments with UCLAs B Select an Inclusive UCLA Abutment Select the appropriate Inclusive UCLA based on the implant system platform size and connection interface engaging or non engaging m Produce the Working Model 1 For elastomeric impressions created with the closed tray technique confirm that the transfer copings are placed appropriately within the elastomeric impression 2 Ensure each captured transfer coping is fitted with a fully seated implant analog and that there is no lateral movement of the analog If movement is observed a new impression is required 3 Follow pouring procedures for the appropriate die stone to produce a working model For subgingival bone level implants it is highly recommended that a soft tissue model be fabricated by syringing soft tissue material around the analog coping interface prior to pouring the die stone 4 For impressions created with the open tray technique unscrew and remove the guide pin from the underside of the impression tray before separating the model from the impression B Wax Up the UCLA 1 Seat the chosen Inclusive UCLA Abutment onto the implant analog in the stone model and hand tighten using the Inclusive Titanium Screw provided with the appropriate driver If the UCLA is engaging be sure the interlocking features are fully connected 800 407 3379 B www glidewelldirect com 26 2 Make shape and height adjustments to the plastic sleeve as necessary for occlus
72. wns and bridges cementable or screw retained fixed removable full arch prostheses or attachments for securing removable implant overdentures The procedures and guidelines presented herein are not adequate to allow inexperienced clinicians to administer professional implant restorative dentistry and are not intended to be a substitute for formal clinical or laboratory training Inclusive Prosthetic Components and accessories should only be used by individuals with training and experience specific to their clinically accepted application Prismatik Dentalcraft Inc is not liable for damages resulting from treatment outside of its control Responsibility rests with the provider CAUTION U S federal law restricts these devices to sale by or on the order of a licensed dentist or physician Intended Use Inclusive Prosthetic Components are indicated for use in partially or fully edentulous patients to retain or support maxillary and mandibular single unit multiple unit and overdenture dental restorations in provisional or long term applications For product specific usage please refer to the individual product information sections contained within this manual Contraindications Inclusive Prosthetic Components contain no side effects according to current knowledge Do not use Inclusive Prosthetic Components in patients with hypersensitivity to any material listed in the product description For product specific contraindications please refer
73. y gaps between the framework and the ridge Follow procedures to build a wax occlusal rim on top of the record base Send the record base occlusal rim fixture to the dentist still fastened to the working cast B Take the Occlusal Rim Bite Registration 1 Remove the occlusal rim from the working cast by twisting and removing the guide pins straight up through the access holes 800 407 3379 B www glidewelldirect com 36 2 Seat the record base onto the multi unit abutments on the patient s ridge Hand tighten the record base and occlusal rim fixture to the abutments with the prosthetic screws using the appropriate driver NOTE The alignment procedure may require multiple insertions and removals of the occlusal rim At least two screws should be fastened during registration to ensure proper fit 3 Using a heated Bard Parker knife index the midline and smile line with a notch across the facial aspect of each occlusal rim 4 Modify extraorally as needed with a heated Bard Parker knife to set the vertical dimension of occlusion 5 Usinga heated Bard Parker knife cut a shallow triangular notch into the occlusal surface of each occlusal rim s posterior regions If the patient is completely edentulous be sure the notches in the maxillary and mandibular occlusal rims are slightly offset for successful indexing of the bite registration 6 With the occlusal rim securely fastened by the prosthetic screws syringe sufficient ela
74. y the manufacturer of the implant system being used 3 Itis imperative that all bone and soft tissue be removed from the superior aspect of the implant body to guarantee complete seating of the Locator Implant Abutment 4 A special gold plated Abutment Driver 8390 contained in Locator Core Tool 8393 is designed to engage the inside diameter of the Locator Abutment and thread it into the implant by hand A Locator Abutment Retaining Sleeve 8394 slips onto the Abutment Driver to hold the Locator Implant Abutment while delivering it to the implant site by hand 5 Final torque tightening of the Locator Abutment to prevent screw loosening is achieved using the 30 Ncm Torque Wrench Kit 9020 The 15 mm length Square Drive Torque Wrench Driver 8926 is used when interocclusal space is limited and the 21 mm length 8927 is used when interference is caused by an adjacent tooth 800 407 3379 B www glidewelldirect com 42 NOTE Various connection types of Locator Torque Wrench Drivers are available that fit into commonly used implant torque wrenches to allow direct torque tightening of the Locator Implant Abutment In addition the use of any Torque Wrench with a 050 1 25 mm Hex Torque Wrench Driver Tip will fit into the backside of the Locator Abutment Driver Use your own Torque Wrench with either of these options to achieve 30 Ncm that will help prevent screw loosening of the Locator Implant Abutment B Measure Angle of Diverg

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