User Manual
Contents
1. MIS 1 Guide 2015 MIS User Manual MIS Corporation All Rights Reserved MIS reserves the right to modify the products described in this manual as well as to revise this publication at any time and without informing any person of such revision or change All rights reserved No part of this publication may be reproduced transcribed stored in an electronic retrieval system translated to any language or computer language or transmitted in any form whatsoever without the written consent of the publisher Questions comments or requests will be addressed promptly by contacting MIS specialists directly through our e mailing address service mis implants com The MIS website can be accessed at www mis implants com This online site highlights current products and reflects all new discoveries and developments Note This User Manual is for educational purposes only The MIS Quality System complies with international quality standards ISO 13485 2003 Quality Management System for Medical Devices ISO 9001 2008 Quality Management oystem and CE Directive for Medical Devices 93 42 MIS products are cleared for marketing in the USA and CE approved Overview 12 13 Ti Introduction Raw Material Manufacturing Process Implant Surface Histology Hydrophilicity Overview Introduction MIS is a dynamic state of the art production company developing and manufacturi2. The drilling sequence is demonstrated using a 13mm implant Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon 23 Recommended insertion torque 35 60 Ncm 200 ET I Q4 24 20 4 20mm 1200 900 500 400 Drill Speed RPM 1500 1200 es Pl Diameter 21 90 22 40 22 40 23 23 50 G 5mm 1200 900 500 400 Drill Speed arm 1500 12002 A AR Diameter 0190 0240 0240 M3 23 50 200 400 24 0490 99 28 Indications amp Contraindications 30 Step by Step Protocol Indications Adequate bone is needed to support the implant with width and height being the primary dimensions of concern The amount of available bone should be evaluated based on accepted imaging and radiological techniques used in implant dentistry In addition a very careful evaluation must be made as to the location of vital blood vessels nerves maxillary sinus soft tissue spaces and their relation to the site planned for implant placement Contraindications All contraindications associated with elective surgery should be considered 20 These include but are not limited to Metabolic bone diseases Blood and clotting disorders Medications affecting clotting or bone turnover Significant vascular or anatomic factors at the implant site Treatments medications or disorders that interfere with bone biology o
3. The C1 Drill Stopper Kits MK CDS08 MK CDS10 MK CDS11 MK CDS13 are a series of kits each used for one specific implant length 8 10 11 5 or 13mm For commonly used 3 75 or 42 implants MIS offers a single assorted kit the C1 Drill Stoppers Kit Standard Platform MK BC101 which includes all stoppers required for safe placement of Standard platform implants C1 Drill Stoppers Kit C1 Drill Stoppers Kit Standard Platform MK BC101 Implant Length 3mm 37 6mm O3 50mm 37 7mm O4mm 38 2mm O4 50mm 38 2mm 5mm 38 2mm 50 Drills Color Code Color coding is used for easy identification of drills or implants diameters as follows White Implant 26 Drill 4 50 5 52 Drills Drilling Depth Important Please note that the apical tip of all MIS twist drills is up to 0 5mm longer than the depth of the corresponding implant This should be taken into account during the planning phase Geometrical difference between the drill tip and the implant Depth Verification Depth verification can be done by the use of Body Try In tools MT BTTx Laser markings correspond to those on the drills and allow a safe easy way to ensure that the required depth was achieved 16mm 13mm 13mm 11 5mm 11 5mm 10mm 10mm 8mm 8mm 6mm 6mm gt For demonstration purposes the MT P2413A drill 13mm height with built in stopper is shown 54 Drills Drill Indications Recommended
4. Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel 48 50 52 54 56 58 99 60 61 Using MIS Drills Color Code Drilling Depth Drill Indications Final Drill Drilling Into Hard Bone Drill Cutting Capability Ceramic Drills Drill Maintenance 48 Drills Using MIS Drills Implant placement procedures require the use of several drills with different diameters and characteristics MIS offers drills with internal and external irrigation as well as conical and ceramic drills Most MIS drills are marked for depth control and are color coded for immediate identification of drill diameter Features MIS drills are designed to be used with all MIS implants Drills are available with or without internal irrigation Short drills are also available for each diameter All drills are color coded The drills are marked for depths of 6 8 10 11 5 13 and 16mm and are equipped with a ledge that allows the connection of MIS drill stoppers All MIS drills have a 120 C cutting degree The sharpness and high quality of the drills allow for up to 30 uses Careful use of sharp drills will ensure atraumatic drilling procedures and minimal heat generation Drill Stoppers MIS offers drill stoppers to enable simple and accurate depth control
5. bending strength of 2 000 MPa In comparison the bending strength of zirconium oxide ceramic used in the manufacturing of root posts is 1 200 Mpa Advantages Metal free biocompatible corrosion free Er MT CRD21 MT CRD20 MT CRD28 Marking Drill Pilot Drill Twist Drill Dimensions 2 10mm 2mm 02 80 Length 28 5mm Length 33 5mm Length 35mm Material Zirconia Zirconia Zirconia alumina ceramic alumina ceramic alumina ceramic Drills Drills Maintenance 60 Correct and careful maintenance of MIS drills is extremely important Damage to drill tips can cause significant impairment of drill function The following are detailed instructions for proper maintenance Instructions for Maintenance of Drills Prior to First Use Stage 1 Cleaning and Rinsing Drills should be dipped in appropriate detergent rinsed and dried The use of an ultasonic bath is highly recommended Stage 2 Sterilization Drills should be sterilized in an autoclave at 134 C 273 F for 6 minutes Do not exceed 134 Stage 3 During Use Drills should be soaked in a sterile saline solution until the cleaning stage Instructions for Cleaning and Storage of Drills After Use Stage 1 Cleaning Drills should be brushed with detergent to remove any remaining blood or tissue Stage 2 Ultrasonic cleaning Drills should be cleaned in an ultrasonic bath with appropriate detergent Note during ultrasonic cleaning contact between dri
6. procedure is applicable for Wide platform tools Friction Fit MT RE172 MT RE160 The friction fit extractors are designed to separate the friction fit abutments from the implant The extractors are color coded Blue for Standard Wide abutments and Yellow for Narrow abutments 4 Int connection Int connection abutment extractor abutment extractor NP MT RE172 MT RE160 Mode of action The extractor key applies vertical load parallel to the long axis of the implant Thus it can release a locked abutment from an implant For Standard Wide Implants Platform switching Friction fit For Narrow Implants SOS Broken Screw MT TF172 MT RTOO1 MT HW001 The SOS Broken Screw Kit was designed to facilitate the removal of a broken screw from within an implant SOS Broken Screw Kit MK 0041 SOS Tools Thread Former Retriever MT TF172 MT RTOO1 Hand Wrench MT HW001 Instructions for use si 2 S A Connect the retriever to a A Apply mild pressure with the If internal threads are damaged micromotor retriever at the top of the broken ih Use the thread former with care B Adjust the micromotor to un low speed 15 25 RPM max B While maintaining pressure B Be sure to align the thread torque and in reverse mode activate the motor This action former parallel to the long axis of should release the screw If the the implant intermittent pressur
7. risk factors to the patient s health and to implant success Therefore no implant placement procedure should be performed without prior training by a certified institution 30 The surgical manual is designed to provide an overview of the pre surgical and the surgical procedures applicable to the C1 implant range Successful implant placement procedures are the result of a wide range of factors This step by step protocol aims to ensure that significant factors are not overlooked Step 1 Patient Selection and Medical History General medical history Patients must be carefully assessed for their ability to safely undergo surgical procedures Medical history should be evaluated to ensure that patients are not put at risk Certain medical conditions are considered either absolute or relative contra indications for surgery These may relate but not be limited to the following conditions Patients who are either taking or have taken medications for the treatment of osteoporosis immunodeficiency or immunosuppressive treatments malignancies head and neck radiation poorly controlled diabetes or other hormonal disorders bleeding disorders or anticoagulant therapy recent myocardial infarction severe cardiac insufficiency and valve pathology general bone diseases hypersensitivity or known allergy to specific relevant materials psychiatric or personality disorders that limit or interfere with patients understanding and co
8. 2596 relevant for use with panoramic radiographs that include a similar inherent magnification In addition the transparency includes a 1 1 ruler By placing the appropriate section of the transparency on a radiograph a clinician can choose the best fitting implant diameter and length as part of the planning process The transparency available for C1 implants is Cat No MC CONC1 mis c1 N a8 db Ge OR beaj 91 Symbols Key to symbols on labels and instruction leaflets LOT Batch code Manufacturer Catalog number Do not resterilize 2 For single use only Do not use if package is damaged N Attention see instructions for use Authorised representative in the European community Date of manufacture mr Use by date STERILE R Sterilized using gamma irradiation ED ee All rights reserved No part of this publication may be reproduced transcribed stored in an electronic retrieval system translated into any language or computer language or be transmitted in any form whatsoever without the prior written consent of the publisher Warning Only a licensed dentist should use these products 4104 Ady ISIDNN AN MIS Implants Technologies Ltd www mis implants com MIS Quality System complies with international quality standards ISO 13485 2003 Quality Management System for Medical Dev
9. Speed Spade Drill Marking Drill Pilot Drill Twist Drill Length amp Diameter The Spade Drill has a diameter of 1 9mm and a sharp tip The Spade Drill is 275mm in length and made of stainless steel The Marking Drill supplied is 34mm in length and 1 90mm in diameter Aim of Use The Spade Drill is used to mark a reference point for further drills It is especially useful in immediate placement procedures The Marking Drill is used for creating a reference point in the center of the ridge and to mark the location for further drilling C1 Final Drill Final Drill for implant diameters 23 30 03 75 04 20 25 23 50 04 10 3 20 C1 Implant and Drill Measurements Each C1 implant package contains a sterile single use Final Drill The drills are recommended for use in bone types 1 2 amp 3 Each Final Drill has a predetermined length and diameter matching the relevant implant shape and dimension ensuring maximum initial stability while preventing pressure on the implant neck The length specific final drills also promote a short and safe drilling procedure The recommended drilling speed is 200 400 Rom Implant and drill measurements amp 3 30mm amp 3 75mm amp 4 20mm 5mm 03 20 22 40 04 0 Gap Ga 4 0 4mm 0 15 58 Drills Countersink Drills When drilling into hard bone extra care should be exercised to prevent overhea
10. Tryin A 0 MT DEOO1 115 BELED ebe TION 5 005 Drills 224 LE u 0 05 i EH L 2 Hex MT LMO05 Drills Ratchet VE p Adapter zm dimana T P2411 i EA MT p2413 Q u aem R 2416 n The C1 Surgical Kit includes tools that are designed especially for the step by step implant placement process Correct preparation of the implant site ensures efficient and accurate installation and high primary stability Direction Indicators Insertion Tools BUCCAL Parallel Pins d PROCEDURE GUIDE 9 3 2 d L Body Tryin E i 15 _ D S victDrils ET K Ratchet apter 2406 2408 2410 2411 2413 2416 24 28 2 MT BTT40 MT BTT45 MT BTT50 MT TDN3O Pilot drill with built in stopper 22 40 height 6mm Pilot drill with built in stopper 22 40 height 8mm Pilot drill with built in stopper 22 40 height 10mm Pilot drill with built in stopper 22 40 height 11 5mm Pilot drill with built in stopper 22 40 height 13mm Pilot drill with built in stopper 22 40 height 16mm Body try in 22 40mm for tapered impl procedure Body try in 22 80mm fo
11. arefully prior to use Implant package 10 Implant Package A convenient 10 implant package is available The drawer like box is ideal for storage in drawers or cabinets for easy identification of implant type diameter and length 4 Insertion the adapter Double Container System Cover screw To ensure that implants are sterile and to prevent surface contamination each implant d 1 is stored in a Titanium sleeve within an internal 5 plastic tube This tube is held a larger N sealed outer tube marked with all relevant 1 J information The inner tube is therefore sterile e and can be brought into the sterile surgical field whenever needed Implant Identification markings on the outer tube cap enable quick identification of implant diameter top implant length center and implant platform size bottom Implant diameter AD Implant length mm Implant platform J y K LN Y 81 Each package contains three data labels which includes all required information pertaining to the implant The following image illustrates the label Catalog No 3 75x11 50 Type of implant amp connection C1 11375 C1 conical connection implant dia 3 75 L 11 50mm Implant diameter amp length Lot 123456 ell 2005 12 lt 2010 12 C Lot No Date of manufacture CE Mark Use by date 82 Th
12. astening Excess loads may result in damage to implants components screws the wrench itself and even to the bone to implant interface Ratchet Wrench MT RIO30 we Instrument Maintenance The device is not sterile Cleaning and sterilization are required prior to first use Clean instrument with running water to remove any blood or tissue immedi ately after use Cleaning and Disinfection Immerse instrument in an approved cleaning disinfecting solution Use of an ultrasonic cleaner is highly recommended DO NOT USE agents containing high cocentration of chlorine or agents containing oxalic acid Use distilled water to prevent water stains User Instructions Store the ratchet on its own not attached to any tools Sterilization All dental instruments must be sterilized prior to each use he device is delivered non sterile Before use the device must be sterilized by autoclave at 134 C 273 F for 6 minutes Do not exceed 134 Clean thoroughly immediately after use 66 Implant Site Depth Probe MT BTIHO Implant size based ruler HA N Features The Depth Probe enables quick and easy to ensure accurate placement within the measurements and examination of a prepared ossteotomy implant site at each step of the procedure Dimensions Total Marked depths 6 8 10 11 5 13 and 16mm length 100mm The Depth Probe includes an apical fla
13. ay support repeated exposures to temperatures up to 180 C but the lifetime of the trays may be shortened The use of inappropriate chemical agents may cause damage to the trays and to the instruments Please handle them with care to avoid breakage Never use broken trays or instruments Do not open the box while still hot after sterilization Cleaning Procedure Stainless steel instruments should be cleaned and sterilized with materials that are specifically indicated for these materials To avoid damage please refrain from using s Cleaning and disinfection agents containing high rates of chlorine Cleaning or disinfection agents containing oxalic acid In order to prevent damage to instruments that are color coded please refrain from using s Detergents and cleaning agents containing high rates of the aforementioned chemicals s Extremely high temperature during cleaning and sterilization Please Note s Conduct a visual inspection of the instruments prior to each use Do not use faulty or dull instruments Clean and disinfect each instrument separately Do not allow traces residue blood secretion tissue residue to dry on the instruments Always soak in disinfecting fluid immediately after use Use only stainless steel dedicated detergents and strictly follow usage instructions Rinse instruments thoroughly with water to remove any remaining disinfectants or cleaning agents Do not store instruments that are
14. damp or wet Use only nylon bristle brushes to clean instruments Clean the cavities and hollow spaces thoroughly The use of an ultrasonic bath is highly recommended Do not clean disinfect instruments made of different materials together To prevent damage do not allow sharp instruments to touch other instruments during cleaning After mechanical or manual cleaning all surgical appliances must be sterilized in an autoclave at 134 C 273 F for a duration of 6 minutes Do not exceed 134 C Never use dry sterilizers Inspect for corrosion after sterilization 0044 With external irrigation drills CS PF375 Direction Indicators ee 5 23 4 Countersink CT SLI10 CT SSI10 MT CSN33 nD MT GDN33 1 MT GDN50 mR 24 MT BTTSO MT BTT35 MT TDTSO MT TDT35 J Direction CN PF330 Indicators 2408 O CT NLHO MT P2410 MT SMD10 CT NSI10 di MT BTT40 MT BTT45 MT BTT50 CW PF500 CT WSI10 CT WLI10 a E sie MT RIO30 I Direction Indicators 25 P MT TDT40 nserten Dh 9 Tools N MT TDT45 045 S Parallel Pins di MT TDT50 DURE 3UIDE z Zu MT PP240 10
15. e distinctive blue C1 implant boxes are a uniform shape and height specifically designed to fit in clinic cabinets for easy accessibility and compact space saving storage Screw Type CONICAL CONNECTION Fig 1 The convenient pull tab facilitates easy quick opening of the box during surgery 83 Fig 2 Open the outer tube by turning the cap counter clockwise Drop the sterile inner tube into the sterile field Fig 3 The implant is held by the titanium sleeve To expose the implant hold the tube with the titanium sleeve facing up Rotate and pull to open the upper cap 84 Use one of the following options to remove the implant from the inner tube Fig 4 Contra angle hand piece Fig 4B Hand wrench 85 Fig 5 Ratchet Fig 6 Implant placement illustrated using a manual wrench 86 Fig 4 Implantation procedure Fig 8 Open the bottom of the inner tube Remove the cover screw using the MT LMOOS5 key 87 Fig 9 Attach the cover screw to the implant using the 1 005 key Fig 9 The data labels should be attached to the medical chart jue duu JSpul Ao M9JOG JAAOD san Jeino san Jeuu 1401 8014 90 Planning Transparency MIS offers a planning transparency illustrating the full C1 implant range It includes two sets of images one actual size and the other at a magnification of 1
16. e on the screw wrench Apply gentle but firm force while turning the thread former in a clockwise direction Release the pressure at the end of each complete turn by turning it 30 in a reverse direction and repeat the action as needed D In instances where greater torque is needed a ratchet may be used Load N Max force N 14 Tensile test of dental screws Lu Ti screw 2mm 1600 4 Gold screw 2mm 1400 1200 1000 800 600 400 200 0 0 2 04 0 6 0 8 1 1 2 14 1 6 Displacement mm Fatigue test of dental screws 1600 1400 Ti screw 2mm 1200 1000 Test conditions 20 Ti 6AI AV ELI M2 type screws Loading frequency 30Hz 800 600 400 200 Test results indicate that the fatigue limit of the tested screws is 530N and that the screws will not break even after 5 million cycles 1 E 03 1 E 04 1 05 1 E 06 5 E 06 1 E 07 Number of cycles fo The wide variety of MIS surgical tools requires careful maintenance L Instrument maintenance MIS surgical instruments are delivered non sterile unless indicated otherwise Disinfection Immerse instruments immediately after use Use approved agents only Observe manufacturer s recommendations regarding concentration time material compatibility Verify that detergents and cleaning agents do not contain oxalic acid or high rates of chlorine Avoid extremely high temperatures during clea
17. gic section of a C1 implant 5 weeks after placement Courtesy of Paulo G Coelho DDS PhD NYU College of Dentistry Histologic section of a C1 implant 5 weeks after placement Courtesy of Paulo G Coelho DDS PhD NYU College of Dentistry Overview Hydrophilicity Current literature demonstrates a linkage between improved bone healing and early osseointegration with the hydrophilicity of surface MIS implant surface treatment combines sand blasting and acid etching This combination ensures surface purity and hydrophilic properties The images demonstrate liquid climbing upwards on the implant surface 20 Introduction C1 Implant 21 Fixture Technical Info 23 Features 24 Implant Range 25 Procedure MIS is proud to introduce C1 an addition to our implant selection The C1 implants feature a unique combination of attributes that result in a new innovative implant that provides high initial stability and a state of the art conical connection which incorporates platform switching technology A large variety of superstructures and components are available providing solutions for every possible clinical scenario All implants and components are color coded according to their restorative platform with a golden anodized hue for best esthetic results O a ES 10411 ES Conical connection Conical body Surface sand blasted acid etched Tw
18. h 38 2mm 34 50mm Length 38 2mm 5mm Length 382mm Length 275mm 190mm Length 34mm Length 15 5mm Length 29mm Length 24mm Material Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel MT DE001 Drill extender MT PP240 Parallel pin 22 40mm for tapered impl procedure CN PF330 Direct press fit for closed tray coni con NP CS PF375 Coni con direct press fitfor closed tray SP CW PF500 Coni con direct press fit for closed tray WP CT NSHO Coni con short insertion tool NP CT NLHO Coni con long insertion tool NP CT SSI10 Coni con short insertion tool SP CT SLHO Coni con long insertion tool SP CT WSI10 Coni con short insertion tool WP CT WLHO Coni con long insertion tool WP MT CSN33 Countersink for Narrow platform implant system MT GDN33 Countersink for Standard platform implant system MT GDN50 Countersink for Wide platform implant system Dimensions Length 28 85mm 22 40 3mm Length 16mm Length 16 6mm Length 16 6mm Length 22mm Length 30mm Length 22mm Length 30mm Length 22mm Length 30mm 23 30mm Length 26mm M13 75mm 04 20mm Length 26mm 25mm 6mm Length 26 8mm Material Stainless steel Titanium Stainless steel Stainless steel
19. ices ISO 9001 2008 Quality Management System and CE Directive for Medical Devices 93 42 EEC MIS products are cleared for marketing in the USA and CE approved
20. lls should be avoided Stage 3 Rinsing Drills should be rinsed under running water and dried Stage 4 Sterilization Drills should be sterilized in an autoclave at 134 C 273 F for 6 minutes Do not exceed 134 Stage 5 Storage Use Store kits in a cool and controlled environment Please note that sterilization may expire after a certain time If kits have been stored for a prolonged period resterilize them prior to use 61 Recommendations Cutting tools should be used for a maximum of 30 uses Distilled water should be used in order to avoid surface stains 184 C 273 for 6 minutes Autoclave for Instruments drills kits Autoclave serialization 1 34 C cycles Minutes 64 T2 76 TE Specialized Surgical Tools Specialized Prosthetic Tools Screw Tests Maintenance 64 The new ratchet is a mono block instrument with a unique mechanism that simplifies use and cleaning To prevent damage to the mechanism it is critical that the ratchet is used only with keys and adapters that are specifically designed for it The ratchet wrench can be used for implant placement and tightening or loosening screws Warnings It should be emphasised that MIS recommends the use of a torque controlled driver whenever possible The Ratchet Wrench MT RIO30 may transfer torque levels that do not correlate to the recommendations specified for implant placement or screw f
21. mate dental and medical titanium grade Similar to commercially pure titanium Grades 1 4 the outer surface of all MIS implants are comprised of a thin layer of pure titanium oxide TiO In this way bone cells cannot differentiate between the different titanium grades The TiO layer also prevents metallic ions leaking from the alloy for safe long term use Mechanical Properties Raw Material 113 860 TI BAIAV EL E Shock ee Durability to Absorbency Deformation ELM H Lorem Modulus of elasticity Yield strength 1000X N mm min N mm T Grade4 103 480 Ti 6AI AV ELI Ti Grade 4 Ti GAI AV ELI gt Ti Grade 4 Ti GAI AV ELI gt Ti Grade 4 930 ee Durability to Fracture Tensile strength min N mm 550 10 Overview Manufacturing Process otructure Raw Material MIS Surface Treatment Acid Etching Sand Blasting Roughness Macro and Nano Structures The combination of sand blasting and acid etching induces macro and nano structures that significantly increase surface area of the implant body for optimal osseointegration The roughened surface improves bone adhesion as well as the proliferation and differentiation of osteoblasts 11 Overview Implant Surface Osseointegration is defined as the attachment of bone to dental implants and is the critical factor related to the long term success of dental implant
22. mpliance Please be aware of the fact that updates based on current medical literature may include or exclude certain conditions Step 2 Dental Conditions and Oral Hygiene A complete and thorough intraoral examination must be performed and recorded This must include an evaluation of the dentition oral hygiene smoking habits attitude to oral health and any other relevant information Implant procedures should not be performed on patients with active osteolitic conditions active periodontal disease or infectious areas at the implant Site Extreme bruxing and clenching should be taken into consideration Step 3 Radiographs and Imaging Diagnosis and treatment planning for implant placement require the use of different types of radiographs and imaging technologies Panoramic radiographs are considered standard pre surgery radiographs however additional imaging modalities such as CT Computerized Tomography tomography and periapical radiographs may be required It should be emphasized that certain countries require specific radiographs to be taken before during and after surgery It is the obligation of the surgeon to ensure that all required documentation is available and recorded before and after surgery Vertical and horizontal dimensions of implant sites should be measured and charted The anatomical relationships of neighboring teeth and proximity to anatomical structures such as the mandibular canal maxillar
23. n apparatus should be available Warnings C1 implants are supplied in a sealed and sterilized package Implants should never be reused and implants whose sterility is compromised should not be used Implants should not be used later than the specific expiration date printed on the package Implant placement should be performed in accordance with acceptable placement and loading protocols MIS recommended procedures are described on pages 20 43 However it should be emphasized that procedures recommended by MIS cannot replace the judgment and professional experience of the surgeon The sale of MIS implants is restricted by law to licensed dentists only Implant placement procedures should only be performed by trained and licensed dentists Initial planning is of the utmost importance As this is a prosthetic driven procedure It is advisable that restorative dentists are involved at the planning and surgical phases as active participants when making decisions affecting the choice of implant type and the 3 dimensional positioning of the implants 12 24 Step 6 Osseointegration Phase Current literature supports multiple loading options The dentist should decide when to load implants based on specific parameters related to their individual case Step 7 Hestorative Phase C1 implants can support different types of final restorations Following the solution specified in the treatment plan the final restoration is fab
24. ng a comprehensive range of dental implants designed to provide long lasting successful solutions to partial and complete edentulous conditions MIS implant systems combine several advantageous elements such as choice of raw materials macro structure micro structure and surface treatments in order to achieve high primary stability and successful osseointegration MIS upholds high quality standards by conducting comprehensive quality assurance evaluations throughout the entire production process The unique MIS implant surface treatment combines sand blasting and acid etching to increase surface area creating both micro and nano structures and eliminating surface contaminants The implant surface is continuously monitored by a comprehensive series of tests conducted both in house and by internationally recognized research institutes Tests include Mechanical tests XPS analysis Roughness analysis Surface analysis SEM evauations Cytotoxicity tests Sterility validations Torque removal values Histology Ove rview Raw Material Biocompatible Safe Long term proven clinical success Superior mechanical properties All MIS implants are made from Ti 6Al 4V ELI Grade 23 the higher purity version of Ti 6AI 4V This specific type of alloy combines biocompatibility excellent fatigue strength and low elastic modulus These benefits make Ti 6Al 4V ELI mechanically superior to titanium grade 4 and the ulti
25. ning and sterilization of the product Cleaning Remove all residues Use an ultrasonic bath Use anticorrosive cleaning agent Thoroughly rinse away cleaning and disinfecting agents with running water Use distilled water to prevent water spots Drying Allow instruments to dry prior to sterilization Examination Perform a visual inspection Dispose of damaged instruments Check for Broken or dull drill blades Bent instruments Corrosion Sterilization Surgical instruments must be sterilized before use by autoclave at 184 C 273 F for 6 minutes Do not exceed 134 C Storage Store in a dry dust proof area Keep instruments separated from chemicals Resterilize prior to use if instruments have been stored for a prolonged period of time 80 Implant Package 82 Implant Identification Codes 83 Implant Data Label 84 Implant Package Handling 78 The innovative MIS packaging system is designed for simple and easy use All of our implant boxes feature distinctive colors large typeface clear data labels and a pull tab for quick opening Boxes are a uniform shape and height specifically designed to fit in clinic cabinets for easy accessibility and compact space saving storage The Individual Implant Package Each C1 package contains Instruction For Use an implant a single use final drill a cover screw and a PEEK temporary cylinder We recommend instructions be read c
26. o spiral channels Domed apex Dual thread Micro rings Platform switching Platform switching The C1 features platform switching that keeps the implant abutment connection away from the bone minimizing bone resorption Platiorm switching additionally allows more vital growth of the soft tissue Conical shape The conical root shape of the C1 implant and a unique thread design ensure superior primary stability making the C1 the implant of choice for a wide range of clinical cases and loading protocols The root shape design makes the C1 an ideal implant when space is restricted due to adjacent teeth or implants Two spiral channels and domed apex The C1 features a domed apex providing a high tolerance and safe procedure during insertion Two cutting blades at the implant apex establish the self tapping properties of the C1 supporting a simpler safer and faster procedure 20 Dual thread The C1 features a dual thread design which increases the BIC Bone to Implant Contact over the entire body of the implant The dual thread doubles implant insertion rate 1 50mm facilitating a simpler and faster implant placement The thread profile is especially designed for a flawless easy insertion and a high primary stability The C1 isselftaping with mild bone compression that enhances primary stability Surface treatments C1 implants are sand blasted and acid etched These surface treatments inc
27. r tapered impl procedure Body try in 23 20mm for tapered impl procedure Body try in 24mm for tapered impl procedure Body try in 24 50mm for tapered impl procedure Body try in 5mm for tapered impl procedure Twist drill 3mm external irrigation Dimensions 22 40mm Length 31 8mm 22 40mm Length 31 8mm 22 40mm Length 31 8mm 22 40mm Length 31 8mm 22 40mm Length 31 8mm 22 40mm Length 31 8mm 22 40mm Length 28 5mm 22 80mm Length 28 5mm 3 20mm Length 28 5mm 4mm Length 28 5mm 04 50mm Length 28 5mm 25mm Length 25 5mm 3mm Length 37 6mm Material Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel SS AS Ta BL MT TDT32 MT TDT40 MT TDTA5 MT TDT50 MT SMD10 MT TDN19 5 10 MT LMOOS MT SMOOS 44 Twist drill 3 20mm external irrigation Twist drill 4mm external irrigation Twist drill 4 50mm external irrigation Twist drill 5mm external irrigation Spade marking drill Marking drill 21 90mm external irrigation Square connection to ratchet adapter Long motor adapter for 0 05 hex Short motor adapter for 0 05 hex Dimensions 3 20mm Length 375mm O4mm Lengt
28. r wound healing Hypersensitivity or known allergy to any components of the implants or their superstructures Other Contraindications Poor patient motivation Psychiatric disorders that interfere with patient understanding and compliance with the necessary procedure Unrealistic patient expectations Unattainable prosthodontic reconstruction Inability of patient to manage oral hygiene Risks Risks associated with the surgical procedure fall into four broad categories 1 Immediate anesthetic and surgical risks 2 Psychological and psychiatric risks 3 Medical threats to long term retention 4 Long term deleterious effects of implants on health The risks may include Inadvertent perforation of the nasal maxillary sinus local and systemic infections perforation into soft tissue spaces rupture of primary blood vessels and nerve injury Temporary conditions that might result from implant placement may include pain and swelling speech difficulties and haemorrhage Long term complications may include but are not limited to nerve injuries and persistent local or systemic infections Special care and attention needs to be given to susceptible individuals with compromised immune systems due to medications systemic conditions or those who underwent body part replacements Important Warning Practitioner s lack of adaquate training knowledge and experience are considered major
29. rease the implant surface area by creating both micro and nano structures and eliminating various surface contaminants Micro rings Atthe neck of the C1 micro rings significantly increase the BIC Bone to Implant Contact avoiding bone resorption at the crestal zone Length 8mm C1 08375 C1 08420 C1 08500 5mm Screw type implant Wide platform 10mm C1 10330 C1 10375 C1 10420 C1 10500 11 50mm 13mm 16mm C1 11330 C1 13330 C1 16330 1 11375 1 13375 1 16375 C1 11420 1 13420 1 16420 1 11500 1 13500 C1 16500 Implant package includes a cover screw a temporary cylinder and a final drill The C1 features a 6 degree conical connection to ensure a secure fit between the abutment and implant By minimizing micro movement at that junction bone loss at the crestal level is reduced There is a six position cone index within the conical connection to help orient the implant during insertion as well as placing the abutment into the proper position Narrow Platform Standard Platform Wide Platform 3 30 83 75 24 20 24 Recommended insertion torque 35 60 Ncm 200 g3 30mm 2 1200 900 Drill Speed apm 1500 120 en 1825 Diameter 01 90 02 40 12 40 3 60 93 30 03 75mm 200 1200 900 500 400 Drill Speed RPM 1500 1200 ___ 700 db 19 25 Diameter 0190 0240 0240 Qa 23 0360 23 75 4 Do not use the final drill for type 4 bone
30. ricated based on accepted restorative protocols Special attention should be given to ensure correct occlusal adjustment in order to prevent overloading the implant MIS superstructures and components must be used with all MIS implants Step 8 Follow up Periodic follow up evaluations including radiographs are recommended Special attention should be put on oral hygiene and habits occlusion adjustments and the stability of the prosthesis 36 Surgical Kit Description 38 Advanced Surgical Instrument Kit 40 Kit Contents 36 The Surgical Kit Surgical Kit Description The C1 innovative surgical kit is designed for simple and safe implant placement procedures The kit introduces a novel ergonomic design that follows the surgical drilling sequence In addition the kit includes a set of length based pilot drills and color coded visual cues of both implant diameter and restorative platforms MK 0044 C1 Surgical Instruments Kit Please Note The surgical kit is made of medically approved materials The surgical kit can be fully sterilized using an autoclave at 134 C 273 F for 6 minutes Do not exceed 134 The surgical kit is compact and easy to store Tray can be removed from the box for easy cleaning and sterilization Steam flow is optimized through built in vents Warning Avoid damage Temperatures higher than 150 may cause damage Radel steel and silicone components m
31. s Osseointegration is determined by both the raw material of the implant morphology and surface chemical composition SEM image of two C1 implants SEM image of the implant surface Macro structure The geometric design of the body and thread profile of the implant act to increase primary stability and to distribute forces from the implant to the surrounding bone Micro and nano structure All MIS implants are sand blasted and acid etched This surface treatment increases the implant surface area creating both micro and nano structures while eliminating various surface contaminants MIS is one of only a handful of companies worldwide using electron microscopy on a daily basis for implant quality inspection Sand blasted and acid etched surfaces have been substantially proven to maximize the BIC Bone to Implant Contact achieving immediate and long lasting osseointegration Surface composition The outer surface of MIS implants consist of a thin layer of pure titanium oxide TiO2 Acid etching and packaging processes are performed in a controlled environment clean room to ensure purity and quality Implants are inspected by electron microscope SEM scan and X ray photoelectron spectroscopy XPS to ensure implants are free of contaminants SEM image of the implant surface showing the micro structure SEM image of the implant surface showing the nano structure 14 Overview Histology Histolo
32. t section Implant Direction Indicator CT SDIO1 Connected directly to the implant this surgical instrument enables the visualization of the 3D position of a particular implant The implant indicator features groove marks indicating gingival heights each groove mark indicates 1mm of gingival height The round cavities at the upper section of the tool represent the position of the anti rotational index within the implant Narrow Implant Direction Indicator CN PF330 Coni con direct press fit WE am en for closed tray SP Hi 22 07 CS PF375 gt Coni con direct press fit for closed tray WP CW PF500 68 C1 Insertion Tools C1 implants are divided into Narrow platform implants 3 30mm Standard platform implants 3 75 and 4 20mm and Wide platform implants bmm Long and short insertion tools are available for each of the C1 platforms In order to simplify procedures the 3 in 1 concept was developed This concept is based on the ability of one insertion tool to be used either directly in a motor with a manual wrench or with any of the MIS ratchets Connection Connection Connection to motor to motor to motor Connection to ratchet T Implant index position UE UE mU M mil AER Index adapter A deeem OO d Amewel A A Les cee Insersion tool for use manually Insertion tool for motor Insertion tool for use with Ratchet wrench The same
33. ting Therefore lower speeds and higher torque should be used In addition to prevent extensive pressure on the bone or the need of extremely high insertion torque it is highly recommended to use the appropriate countersink drills at the end of the drilling procedure Countersink Drills MT CSN33 MT GDN33 MT GDN50 Countersink Drills are used to enlarge the crestal area of the implant site preventing excessive pressure on the implant neck Depth marks of 3 30 appear on the Narrow platform Countersink Drill MT CSN33 3 75 and 4 20mm marks appear on the Standard platform Countersink Drill MI GDN33 5 and 6mm marks appear on the Wide platform Countersink Drill MI GDN50 The recommended drilling speed is 200 500 RPM When drilling into hard bone extra care should be exercised to prevent overheating Therefore it is recommended to use lower drilling speeds with higher torque In addition to prevent excessive pressure on the bone or the need for extremely high insertion torque it is strongly recommended to use the appropriate countersink drills upon completion of the drilling procedure Narrow Standard Wide MT CSN33 MT GDN33 MT GDN50 99 Ceramic Drills feature reduced vibration smooth operation and continuous substance removal MIS Ceramic Drills are made from a high performance mixture of zirconium dioxide zirconia and aluminum oxide alumina ceramics The mixture of these two materials provides an above average
34. y sinus and base of the nose must be evaluated Bone inclination and shape should also be taken into account Surgical guides with radiopaque markers are recommended These coupled with computerized tomographic radiographs can later be altered to be used as computer based surgical guides Step 4 Treatment Plan Patient cooperation Based on patients needs alternative treatment plans should be considered and discussed The chosen treatment plan should result in a sequence of actions related to initial preparations surgical phase and a restorative phase Step 5A Implant Selection C1 implants feature a range of diameters and lengths It is recommended that Wide platform implants are used in the premolar and molar areas while Standard platform implants are used in the anterior areas Specific analysis of available bone and distance from vital structures at each proposed site may lead to the choice of specific implant length and diameter however current augmentation procedures may allow the use of longer or wider implants Step 5B Surgical Phase Surgery should be performed under strict infection control conditions Preoperative medications and or antibiotics may be required based on the patient s condition and the extent of surgery and should be decided upon by the operating surgeon Other monitoring measures including blood pressure and pulse measurements should also be considered Emergency resuscitatio
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