RESTORE Implant System - Keystone Dental

1 Trademark AcknowledgementsPrima, PrimaConnex, PrimaSolo, RENOVA, RESTORE , STAGE-1, DynaBlast, DynaGraft D, DynaMatrix, CALMATRIX, CALFORMA, TEFGEN-FD, TEFGEN-PLUS, TEFGENandTiLobe are trademarks of Keystone Dental , Dental , Middlesex TurnpikeBurlington, MA 01803 USACall: 1-866-902-9272 Fax: 1-866-903-9272 Outside the USACall: +1-781-328-3490 Fax: +1-781-328-3400 Authorized RepresentativeKeystone Dental SpAvia A. Fleming, 1937135 Verona, ItalyCall: +39-045-8230294 Fax: +39-045-8250296 Subsidiary: Keystone Dental ABS r , SwedenCall: +46-31-93-68-23 Fax: +46-31-93-68-45 Subsidiary: Keystone Dental GmbHAlfter, GermanyCall: +49-2222-9294-0 Fax: +49-2222-977356 Subsidiary: Keystone Dental , FranceCall: +33-5-62-21-40-45 Fax: products described herein are covered by one or more of the following patents:US 5,996,779, US 6,142,296, US 7,249,949, and applicable international patents are pending.

2 Keystone Dental , Inc. 2010MK40041 Rev. B 07/2010 RESTORE Implant SystemProsthetic ManualIntroductionThis Prosthetic manual is designed to aid clinicians in basic prosthetic procedures using the RESTORE ExternalHex Implant System . The abutment systems described can be used in all areas of the mouth, for single toothapplications, fixed or detachable bridgework and overdenture procedures and guidelines presented in this manual are not a substitute for formal Implant restorationtraining for the restoring doctor and Dental laboratories. It is the responsibility of the clinicians and dentallaboratories to determine the final protocol and component Considerations2-3 Introduction2 Indications2 Sterilization2 Basic Prosthetic Case Design Principles3 Prosthetic Tables4 Accu-Torque Wrenches and Drivers5 Impression Taking Guidelines6-10 Procedure for Taking an Open Tray Impression7-8 Procedure for Taking a Closed Tray Impression 9-10 Cement-Retained Restorations11-19 Cement-on Crown (COC)

3 Abutment SystemLab Preparation of the COC AbutmentImpressioning11 Master Model Fabrication12 COC Abutment Modification12 Metal Framework Fabrication12 Metal Framework Try-in13-14 Porcelain Application14 Final Insertion14 Chairside Preparation and TemporizationChairside Preparation15-16 Fabrication of the Restoration16 Final Insertion16 Custom Abutment Fabrication with the UCLA AbutmentMaster Model and Abutment Fabrication17-18 Final Insertion18-19 Screw-Retained Restorations20-23 UCLA Abutment SystemImpressioning20 Master Model Fabrication21 Abutment Selection21 Metal Framework Fabrication21-22 Metal Framework Try-in22 Porcelain Application22-23 Final Insertion23 Overdenture Restorations24-31 Restorative Options24 Preliminary Considerations25 Snap Abutment SystemTechnical Considerations25O-Ring Abutment SystemTechnical Considerations26 Laboratory Fabrication of a New DentureImpressioning26 Master Model Fabrication27 Abutment Selection andFinishing the Final Prosthesis27-28 Delivering the Final Prosthesis28-29 Alternative ProcedureDoctor Placement of Snap or O-Ring Abutments 30 Master Model Fabrication31 Delivering the Final Prosthesis31 Bar Attachment-Retained Overdentures32-39 UCLA Abutment SystemTechnical Considerations33 Impressioning33 Master Model Fabrication33 Wax Rim Fabrication33 Verification Jig Fabrication34-35 Interocclusal Record35 Denture Wax Set-up and Model Verification36 Denture Wax Try-in for the Patient36 Bar Fabrication36-37 Framework Try-in38 Sectioning Framework Procedure38-39 Processing39 Final Insertion39 Fixed Detachable

4 Restorations40-48 Fixed Detachable Abutment SystemTechnical Considerations40 Abutment Placement and Impressioning40-41 Master Model Fabrication41 Wax Rim Fabrication41-42 Verification Jig Fabrication42 Interocclusal Record42-43 Denture Wax Try-in and Model Fabrication43 Denture Wax Try-in for the Patient43 Framework Fabrication43 Optional Method for a Matrix44-45 Framework Try-in45-46 Sectioning Framework Procedure46 Denture Wax Set-up and Model Verification46-47 Denture Wax Try-in for Patient47 Processing47 Final Insertion48 IndicationsThe RESTORE Implant System is intended for use in either partially or fully edentulous areas in the maxilla ormandible in support of single or multi-unit restorations. The implants also function as terminal or intermediateabutment support for fixed CONSIDERATIONS: Cement-Retained Restorations (Fixed) utilizing multiple abutments Screw-Retained Restorations (Fixed Removable) utilizing multiple abutments Implant or Bar Attachment-Retained Overdenture Restorations Single Tooth Restorations without involvement of adjacent dentitionFederal (USA) law restricts this device to sale by or on the order of a licensed dentist or considerationsSterilizationSelect prosthetic components are provided in sterile, gamma irradiated packaging.

5 Please refer toindividual package labeling to determine if the prosthetic component is necessary, all-metal components can be re-sterilized according to Keystone Dental ssterilization table:Sterilization Table1. Autoclave: 121-124 C (~250 F) 60 minute exposure / 40 minute dry time or 132-135 C (~270 F) 40 minuteexposure / 30 minute dry time. Do not exceed 140 C (~284 F). Always use the dry Dry Heat: 160 C (320 F) 120 minutes (minimum). Do not exceed 170 C (338 F).It is recommended that the proper biological indicators for the selected sterilization method accompany each loadand that the appropriate sterile packaging be used to maintain sterility until Dental does not recommend chemclave sterilization procedures as they may damage surgicaltrays and/or not use the original packaging in the autoclave!

6 Autoclave re-sterilization can only be accomplished byplacing the individual components in the surgical tray, a sealed autoclave bag or in a surgical Key= Note= Tip= Cautiontable of contentsKeystone Dental , ( )1-781-328-3490 (International)Basic Prosthetic CaseDesign PrinciplesEvaluate the following parameters when choosing thenumber of implants for the type of restoration used:PROPER PROSTHETIC LOADING:To ensure proper prosthetic loading, it is necessary todistribute the loads over the greatest bone-to-implantsurface area possible. To do so, place the largestimplant body available that the bone willaccommodate. Long cantilevers and largeinter- Implant spaces should be EDENTULOUS ARCH:For the partially edentulous arch, total Implant supportof the restoration without involving natural teeth, isrecommended when EDENTULOUS ARCH:For a maxillary Implant -supported, fixed detachablerestoration or bar attachment-retained overdenture, implants are usually placed from the bicuspid area inone quadrant of the maxillary arch to the bicuspidarea on the opposite quadrant of the arch to avoid themaxillary sinuses.

7 A fixed detachable restorationusually requires five to six implants , while a barattachment-retained bar overdenture usually requiresfour to six implants . Place the implants assymmetrically as possible to ensure balanced occlusalforces. For a mandibular Implant -supported, fixeddetachable or bar attachment-retained overdenture, implants are usually placed in the symphysis betweenthe mental foramen or distal to the mental foramen,avoiding the anatomical restrictions of themandibular an Implant attachment-retained overdenture, twoto three implants are usually sufficient. Overdentureabutments should not be used if implants aredivergent beyond 15 considerations3 Keystone Dental , ( )1-781-328-3490 (International) tablesKeystone Dental s external hex Dental implants are engineered around three (3) prosthetic table diameters for clinical versatility,stability and strength.

8 Prosthetic Table refers to the outside diameter at the top of the Implant where the prosthetic compo-nent interfaces with the Implant . The RESTORE prosthetic tables are divided into Small Diameter (SD), Regular Diameter (RD) andWide Diameter (WD). Each diameter is described , M. Small Diameter (SD) implants : A Strength Comparison. OralRestorativeUpdateVol. 4, No. 2 (1997).2 Binon, P. Evaluation of Three Slip Fit Hexagonal implants . (1996).3 Binon, P. Test Data Confirms Close Tolerance Machining of RESTORE System . OralRestorativeUpdateVol. 3, No. 1 (1996).4 Slabberkoom, Scott D., , , Wide Diameter implants - A Balanced Design Approach. OralRestorativeUpdate, Fall DiameterSurgical and Restorative Flexibility Used on RESTORE implants . The SD Implant s narrow prosthetic table makes it anexcellent choice when interproximal space is limited.

9 The SD s 1mm tall external hex provides greater supportand tactile feel when seating components, allowing a morepositive seat. The SD is ideal for single tooth restorations due to itsincreased DiameterLeader of the Wides Used on RESTORE and implants . Solid design maximizes overall performance wheninteracting with compressive occlusal forces, off-axisocclusal forces and torsional forces. Provides 79% more surface area and 43% more height4than the standard hex size for unparalleled strength andexceptional resistance to deformation and stripping ofthe abutment screw provides 65% more strength thanthe standard screw for additional resistance tooff-axis loads and improved torque DiameterUniversal Compatibility Used on RESTORE and implants . Design based on 30+ years of clinical research.

10 A leader in prosthetic connection RD implants provide universal prostheticcompatibility with the following Implant systems: Nobel Biocare - , Steri-Oss HL - , Zimmer Taper-Lock - Implant Innovations, 3i - , TableACCU-TORQUE WRENCHESAccu-Torque Wrenches are available in three torque calibrations. Refer to the tablebelow for torque DRIVERSK eystone Dental offers Accu-Torque Drivers in several hex sizes and theRESTORE Product Catalogfor all available sizes and WrenchesAccu-Torque DriversTORQUE GUIDELINES Place the driver into the abutment or fastening screw. Be sure that thehex hole is fully engaged with the driver. With the rounded edge facing downward, seat the torque wrench driverinto the wrench. Place a finger on the head of the torque wrench. Follow the direction ofthe arrow and tighten to the specific torque value stated below.