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inCoris ZI meso Instructions

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1. Adhesive bonding of high strength full ceramic restorations Quintessenz 55 1 33 41 2004 Geis Gerstorfer J PaBler P Investigations of the fatigue behavior of dental ceramics zirconium dioxide TZP and In Ceram Dtsch Zahnartzl Z 54 692 694 1999 Kappert H F On the high strength of dental ceramics Zm 93 7 2003 Kern M Fracture quota lower than the divorce rate ZWL 04 2004 Luthard R Herold V et al Crowns made of high performance ceramics Dtsch Zahnarztl Z 53 4 280 285 1998 Luthard R Herold V et al Crowns made of high performance ceramics Dtsch Zahnarztl Z 53 4 280 285 1998 Luthard et al Comparison of various techniques for the manufacture of crown frameworks from high performance ceramics State of the art of the CAD CAM supported production of full ceramic crowns from oxide ceramics Swiss Dent 19 6 5 12 1998 Marx R et al Crack parameters and Weibull modules subcritical crack growth and long term strength of full ceramic materials Dtsch Zahnartzl Z 56 2 90 98 2001 Report by DGZMK DGZPW Are full ceramic crowns and bridges scientifically recognized Dtsch Zahnartzl Z 56 10 575 576 2001 Schweiger M Zirconium oxide High strength and break resistant structural ceramics Asth Zahnmedizin 5 2004 248 257 Stephan M Coating behavior of veneering materials on dental ceramics Dissertation of Geoscientific Faculty Tubingen 1996 Tinschert J Natt G Spiek
2. Indications for use The Sirona Dental CAD CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple unit cement retained restorations The system consists of three major parts TiBase InCoris mesostructure and CAD CAM software Specifically the InCoris mesostructure and TiBase components make up a two piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity The InCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD CAM types K2244 xxxx K083496 in the Camlog Implant System The CAD CAM software is intended to design and fabricate the InCoris mesostructure The InCoris mesostructure and TiBase two piece abutment is compatible with the following implants systems Nobel Biocare Replace K020646 Nobel Biocare Branemark K022562 Friadent Xive K013867 Biomet 3i Osseotite K980549 Astra Tech Osseospeed K091239 Zimmer Tapered Screw Vent K061410 Straumann SynOcta K061176 For the USA only CAUTION Federal Law USA restricts sale of this device to or on the order of a physician dentist or licensed practitioner Use of inCoris ZI meso blocks and contra indications inCoris ZI meso blocks are used in manufacturing individually designed mesostructures which are glued to a fitting titanium base after milling and sintering Contra
3. New as of 05 2011 The Dental Company Sirona Dental CAD CAM System inCoris ZI meso Zirconium oxide ceramic blocks for inLab Processing instructions Manufacturing mesostructures English US This product is covered by one or more of the following US patents e US7178731 e US7901209 za 5 go 4 osow yz suogut eS za Ti J H osow yz SYODUI e uout 39 s osow z SUODUI feuds Sy e u 011S 04 we 1 Sirona Dental Systems GmbH Zirconium oxide ceramic blocks for inLab 10 11 12 63 33 640 D3487 Table of contents General Scope of supply Material Chemical composition Technical data Indications for use Use of inCoris ZI meso blocks and contra indications Producing the mesostructure 8 1 Scanning designing and milling ereenn 8 2 Design information sic 8 ied 2s eerie denen alia mee attne loeut boo Meane 8 3 Reworking the milled restoration eeeeeeeeeeeeeeeeeeeeeeeeeeees 8 4 Sintering eee rachael dec quers cede ins negi ennaa AEKA A EEEE AANER ikkes aia 8 5 Additional notes procedure after sintering eeeeeeees 8 6 Reworking the sintered mesostructure ceeceeceeeeeereeteereee 8 7 8 ee a A Recommended tools and materials Gluing the mesostructure to the titanium base Information for the dentist VAT STON ZA OM sis theca ee ees cahegee che ceed eee a vlad References D3487 201 05 04 23
4. Reworking the sintered mesostructure The surface condition of ceramic materials is decisive for their bending strength Reworking sintered mesostructures with milling tools must be avoided at all costs Therefore make corrections to the ground mesostructure if possible before sintering However if reworking should be necessary comply with the following basic rules e Reworking in the sintered condition should be performed with a wet grinding turbine approx 2 5 3 bar or rubber polishers low speed or for primary telescopes with a grinding unit using water cooling and with low grinding pressure As an alternative it is possible to rework with soft diamond rubber polishers and a handpiece at low speed and low pressure The tool must be applied flat and must not chat ter e New diamond burrs with varied grain size should be used if possible e Areas that are under tension in clinical use should not be milled e We recommend subjecting the framework to thermal treatment after the milling process to reverse any phase transformation which may have occurred on the surface Microscopic cracks can not be regene rated The following firing adjustment should be selected for this purpose Vitec gt fA A ca Temp Teel WAG min min C min min min 500 5 00 100 1000 15 00 Sand blast the surfaces on which a superstructure is to be conventionally attached or glued using the one way blasting process
5. 05 2011 10 10 10 10 10 11 11 12 13 14 15 15 16 General Sirona Dental Systems GmbH Zirconium oxide ceramic blocks for inLab General The product inCoris ZI meso bears the CE mark in accordance with the C provisions of Council Directive 93 42 EEC of June 14 1993 concerning medical devices 01 23 inCoris ZI meso blocks are intended for use in manufacturing individually designed mesostructures which are glued to a fitting titanium base after milling and sintering Please also observe the instructions provided by the manufacturer of the titanium base or the implant Rx only CAUTION Federal law USA restricts sale of this device to or on the order of a physician dentist or licensed practitioner 63 33 640 D3487 4 D3487 201 05 04 23 05 2011 Sirona Dental Systems GmbH Zirconium oxide ceramic blocks for inLab 63 33 640 D3487 D3487 201 05 04 23 05 2011 Scope of supply inCoris Zi meso blocks are each available in two different colors and in two different sizes for connecting to the titanium basis Scope of supply REF Connection size Color 62 31 802 S F0 5 62 31 828 S F2 62 31 810 L F0 5 62 31 836 L F2 1 The letter S and L identifies the connection geometry with respect to the titanium bases The scanbodies are Sirona products and can be procured from dealers Lab implants and titanium bases can be procured from the implant manufacturer Material Sirona
6. Dental Systems GmbH Zirconium oxide ceramic blocks for inLab Material inCoris ZI meso ceramics constitute blocks comprised of zirconium oxide The blocks are initially delivered partially sintered then enlarged by the inLab CAD CAM system they are individually processed to specification and finally densely sintered The advantages of inCoris ZI meso are e High strength e Resistance to corrosion e Good biological compatibility of the product e Coloration of the blocks to match adjacent teeth 63 33 640 D3487 D3487 201 05 04 23 05 2011 Sirona Dental Systems GmbH Chemical composition Zirconium oxide ceramic blocks for inLab Chemical composition ZrO2 HfO2 Y203 gt 99 0 Al203 lt 0 5 Other oxides lt 0 5 63 33 640 D3487 D3487 201 05 04 23 05 2011 Technical data Sirona Dental Systems GmbH Zirconium oxide ceramic blocks for inLab Technical data The following specifications apply to material that is densely sintered in an inFire HTC sintering furnace Density 6 06 g cm Fracture toughness KIC 5 9 MPa m12 Thermal expansion coefficient 20 500 C 11 0 108 kK Bending strength 1200 MPa Colors The blocks are tinted in the colors e F0 5 e F2 Therefore it is not necessary to carry out subsequent coloring using a submersion solution or liners 63 33 640 D3487 D3487 201 05 04 23 05 2011 63 33 640 D3487 D3487 201 05 04 23 05 2011
7. with maximum 50 um corundum Al203 Pressure lt 2 5 bar Observe the operator manual of the respective restoration material as to the suitability of the fastening material 11 Producing the mesostructure Sirona Dental Systems GmbH Veneer Zirconium oxide ceramic blocks for inLab NOTICE Observe usage information Etching with hydrofluoric acid does not produce a retentive surface Si lanization is not required Please observe the information on use of the fastening materials of the corresponding manufacturers Veneer The areas of the mesostructures to be veneered that are made of inCoris Zl meso must not be sandblasted Sandblasting could lead to an undesirable phase transformation of the zirconia For the veneer this would cause complex diffusions of stress along the interface which might lead to cracks or late cracks in the veneer after the restoration is inserted Mesostructures made of inCoris ZI meso can be veneered using all standard veneer ceramics for zirconium oxide ceramic In this case the processing instructions of the manufacturer must be observed without fail 63 33 640 D3487 12 D3487 201 05 04 23 05 2011 Sirona Dental Systems GmbH Recommended tools and materials Zirconium oxide ceramic blocks for inLab 63 33 640 D3487 D3487 201 05 04 23 05 2011 Recommended tools and materials Modeling wax Scan wax Sirona suitable for scans with the inLab scanner not for exposures with inE
8. 003 10 63 33 640 D3487 D3487 201 05 04 23 05 2011 17 We reserve the right to make any alterations which may be required due to technical improvements Sirona Dental Systems GmbH 2010 2011 Sprache englisch US Printed in Germany D3487 201 05 04 23 05 2011 A Nr 114 160 R Sirona Dental Systems GmbH in the USA Fabrikstra e 31 Sirona Dental Systems LLC Order No 63 33 640 D3487 64625 Bensheim 4835 Sirona Drive Suite 100 Germany Charlotte NC 28273 Www sirona com USA
9. ermann H Current positioning of dental ceramics Dental Praxis XVIII 9 10 293 309 2001 Vollmann M Innovative DeguDent full ceramic system as a benchmark for the processing of zirconium oxide IJCD 2004 7 279 291 Stephan M Corten A Aluminum oxide corundum mineralogical analyses of corundum Quintessenz Zahntech 31 2 128 133 2005 VITA In Ceram 2000 AL CUBES for inLab VITA full ceramics page16 63 33 640 D3487 D3487 201 05 04 23 05 2011 Sirona Dental Systems GmbH References Zirconium oxide ceramic blocks for inLab CEREC inLab Baltzer A Kaufmann Jinoian V CAD CAM in dentistry CEREC inLab Dental Labor XLIX Volume 5 2001 David A CEREC inLab The CAD CAM System with a Difference CJDT Spectrum September October 24 28 2002 Kurbad A Reichel K CEREC inLab State of the Art Quintessenz Zahntech 27 9 1056 1074 2001 Kurbad A Manufacturing In Ceram bridge frameworks with the new CEREC technology Quintessenz Zahntech 27 5 504 514 2001 Tsotsos St Giordano R CEREC inLab Clinical Aspects Machine and Materials CJDT Spectrum January February 64 68 2003 Preparation illustrations on p 5 accd to Dr Andres Baltzer CH Rheinfelden Kern M Computer aided crown and bridge technology with new perspectives Quint Zahnt 30 9 966 973 2004 Rudolph H Quaas S Luthard R G CAD CAM New technologies and developments in dentistry DZZ 58 2
10. indications are e Insufficient oral hygiene e Insufficient space available e Bruxism e For restorations with angulation correction to the implant axis e For individual tooth restorations with free end saddle e For restorations whose length exceeds a ratio of 1 1 25 in compari son to the length of the implant 10 Producing the mesostructure Scanning designing and milling More details can be found in the following documents e inLab 3D User Manual e inLab 3D for Abutments User Manual 1 Plug a scanbody onto the lab implant of the master model until it co mes to rest on the shoulder of the implant without any gaps The scanbody is scannable without powder or scan spray 2 Record the situation using inEos inEos Blue CEREC 3 Acquisition Unit CEREC AC or from a duplicate model with the scanner inLab inLab MC XL 3 Use the inLab 3D for Abutments software to design the individual shape of the mesostructure and mill the shape from an inCoris Zl meso block see inLab 3D inLab 3D for Abutments User Manual The following information must be observed when designing rewor king and sintering zirconium oxide Design information e Maintain a minimum wall thickness of 0 5 mm circularly around the screw channel e Design the outer form of the mesostructure in adherence to the pre paration guidelines for the required superstructure e If the mesostructure is to be veneered immediately make sure that this doesn t na
11. ium base The contact surfaces of the titanium base to the implant should not be sand blasted or otherwise processed The diameter of the titanium base should not be reduced e g by grin ding Shortening the titanium base is not recommended The surfaces of the titanium base intended for gluing to the zirconium oxide ceramics have to be sand blasted and cleaned Surfaces of the zirconium oxide ceramics and the titanium base to be glued must be free of dust and grease 1 Sand blast the gluing surfaces of the zirconium oxide ceramics and the titanium base with 50 um aluminum oxide and up to 2 0 bar 2 Clean the adhesive surfaces with alcohol or steam For easier hand ling during the gluing process it is recommended that the titanium base be screwed into a lab implant or a polishing tool 3 Cover the hex head of the abutment screw with wax Use PANAVIA F 2 0 www kuraray dental de extraoral as the adhe sive for connecting the titanium base and the zirconium oxide ceramics 4 Mix the glue according to the manufacturer s instructions and apply it to the titanium base 5 Press on the customized zirconium oxide ceramics as far as it will go Make sure it latches into the rotation and position stops 6 Immediately remove any adhesive residue 7 Apply the Airblocker Oxygard to the junction where the ceramic and titanium surfaces meet and to the screw funnel for final harde ning 8 Remove residue wi
12. os Wet grinding turbines KaVo K AIR plus KaVo IMAGO Steco System Technik GmbH amp Co KG NSK Presto Aqua Girrbach Turbo Jet Acurata Grinding tools for reworking with the wet grinding turbine with hand piece Diamond grinding element sets Ceramic Line Telescope Line Sirius Dental Innovations Diamond porcelain polisher for handpiece green orange Hager amp Meisinger Art No HP 803 104 372 533 170 Diamond polisher for handpiece green and orange EVE Diace ra Other Suitable colored contact materials Preparation sets Preparation set acc to Kupper Hager amp Meisinger Art No 2560 Preparation set acc to Baltzer and Kaufmann Hager amp Meisin ger Art No 2531 13 Gluing the mesostructure to the titanium base Sirona Dental Systems GmbH Zirconium oxide ceramic blocks for inLab Gluing the mesostructure to the titanium base Prior to gluing check to make sure that the mesostructure can be easily placed on the titanium base No gap should be visible between the mesostructure and the attachment surface of the titanium base The anti rotation groove has an especially narrow tolerance If the mesostructure cannot be easily positioned first check to see if a small amount of material has to be removed from the groove see Reworking the sintered mesostructure gt 11 Observe the manufacturer s instructions for handling the titan
13. rrow the screw channel The connection point to the base and the screw channel should not be coated e Make sure that no sharp edges or corners are produced Reworking the milled restoration After finishing the milling process and prior to sintering the milled mesostructure separate it from the remaining block and remove the pin with a diamond point tool Sintering inCoris ZI mesostructures have to be sintered in dry conditions The sintering process should be carried out exclusively in the high temperature Sirona inFire HTC furnace Use the SIRONA inCoris ZI program for this As an alternative the sintering process can be carried out in the compatible VITA Zyrcomat or Ivoclar Vivadent Sintramat high temperature furnace Use a zirconium oxide program for this In any case the details in the manuals for the respective furnaces are to be adhered to 63 33 640 D3487 D3487 201 05 04 23 05 2011 63 33 640 D3487 D3487 201 05 04 23 05 2011 Additional notes procedure after sintering In the case of yellow staining of inCoris ZI mesostructures after the sintering process the high temperature furnace should be cleansed by performing an empty run The details in the manuals for the respective furnaces are to be adhered to in this case Sintering beads that adhere are to be removed carefully After the sintering process the inCoris mesostructures must be cooled down to room temperature at atmosphere before further processing
14. th a rubber polisher after hardening 63 33 640 D3487 14 D3487 201 05 04 23 05 2011 Sirona Dental Systems GmbH Information for the dentist Zirconium oxide ceramic blocks for inLab Information for the dentist The inCoris ZI meso blocks are delivered in non sterile condition Observe the titanium bases manufacturer s operating instructions Sterilization The individual abutments must be sterilized prior to insertion Furthermore the locally applicable legal regulations and the hygiene standards applicable for a dental practice must be observed Use only the procedures specified below to sterilize individual abutments Observe the sterilization parameters Steam sterilization can be performed with the fractionated vacuum or the gravitation method The sterilization time is 5 minutes at 134 C 273 2 F and 15 minutes at 121 C 249 8 F Steam sterilization may be performed only using devices that comply with EN 13060 or EN 285 standards It must be ensured that only suitable devices are used to perform sterilization The fabricator dental technician of the TiBase and the mesostructure must inform the dentist of the need to sterilize the abutment before inserting it in the patient s mouth 63 33 640 D3487 D3487 201 05 04 23 05 2011 15 16 References Materials science Baltzer A Kaufmann Jinoian V The toughness of VITA In Ceram Quintessenz Zahntech 29 11 1318 1342 2003 Blatz M Sadan A Kern M

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