Product Catalog RevE - Biomet 3i

1 1 Product Catalog Failure to integrate Loss of integration Dehiscence requiring bone grafting Perforation of the maxillary sinus, inferiorborder, lingual plate, labial plate, inferioralveolar canal, gingiva Infection as reported by: abscess, fistula,suppuration, inflammation, radiolucency Persistent pain, numbness, paresthesia Hyperplasia Excessive bone loss requiring intervention Implant breakage or fracture Systemic infection Nerve injuryInstructions For Use:OSSEOTITE , OSSEOTITE XP , Certain , PREVAIL , Encode , IOL , Miniplant ,MicroMiniplant , GingiHue , Gold-Tite , Provide , STA , ZiReal , CAMS tructSURE , NanoTite , PreFormance , QuickBridge This document applies to dental implants, abutments, overdenture bars andassociated surgical, restorative and dental laboratory detailed information on the specific procedure for the Product you are using,please refer to the individual Product labels and/or the appropriate manual: Product Catalog - Catalog :Listing of all productsSurgical Manual -CATSM:Dental implant placement, surgical protocol and coverscrew insertionRestorative Manual -CATRM:Abutment placement, provisional and finalrestoration protocolsAdditional Restorative Manuals:CAM StructSURE Manual -ART868 DIEM Guidelines -ART860 Encode Restorative Manual -ART924 QuickBridge Manual -ART1016 Description.

2 BIOMET3iDental Implants are manufactured from biocompatibletitanium and titanium alloy and abutments from titanium, titanium alloy, goldalloy and ceramic material. BIOMET3iDental Implants and Abutments includevarious surface treatments and coatings. Other restorative components aremanufactured with titanium, titanium alloy, gold alloy, stainless steel and avariety of specific Product description and net quantity refer to individual for Use:BIOMET3iDental Implants are intended for surgicalplacement in the upper or lower jaw to provide a means for prostheticattachment in single tooth restorations and in partially or fully edentulous spanswith multiple single teeth utilizing delayed or immediate loading, or as a terminalor intermediary abutment for fixed or removable bridgework and to and NanoTite Dental Implants are intended for immediatefunction on single tooth and/or multiple tooth applications when good primarystability is achieved, with appropriate occlusal loading, in order to restorechewing Indications.

3 BIOMET3iDental Abutments and Overdenture Bars areintended for use as an accessory to endosseous dental implants to support aprosthetic device in a partially or edentulous patient. These are intended for useto support single and multiple tooth prostheses, in the mandible or prostheses can be screw or cement-retained to the Abutment Posts and Temporary Cylinders are intended for use as anaccessory to endosseous dental implants to support a prosthetic device in apartially or fully edentulous patient. These are intended for use to support singleand multiple unit prostheses in the mandible or maxilla for up to 180 days duringendosseous and gingival healing and are for nonocclusal loading of single andmultiple unit provisional restorations. The prostheses can be screw and/orcement-retained to the abutment. These Temporary Posts and Cylinders require aminimum interarch space of 6mm and a maximum angulation of 15.

4 These alsoallow for occlusal loading of single and multiple unit restorations of integratedimplants for guided soft tissue QuickBridge Provisional Components are intended to be mated with BIOMET3iConical Abutments for use as an accessory to endosseous dental implants tosupport a prosthetic device in a partially or fully edentulous patient. TheQuickBridge Provisional Components are intended to support multiple unitprostheses in the mandible or maxilla for up to 180 days during endosseous andgingival :Placement of dental implants may be precluded by patientconditions that are contraindications for surgery. BIOMET3iDental Implantsshould not be placed in patients where the remaining jaw bone is too diminishedto provide adequate implant and Handling:Devices should be stored at room temperature. Refer toindividual Product labels and the Surgical Manual for special storage or :Excessive bone loss or breakage of a dental implant or restorativedevice may occur when an implant or abutment is loaded beyond its functionalcapability.

5 Physiological and anatomic conditions may negatively affect theperformance of dental following should be taken into consideration when placing dental implants: Poor bone quality Poor oral hygiene Medical conditions such as blood disorders or uncontrolled hormonalconditionsIt is recommended that small diameter implants not be restored with angledabutments in the molar of small components inside the patients mouth carries a risk ofaspiration and/or the implant into the osteotomy deeper than the depth established by thedrills can result in: stripping the driver hex interface inside the implant, strippingthe driver, cold-welding of the mount-driver interface to the implant or strippingthe walls of the osteotomy that may prevent an effective initial implant data have demonstrated enhanced performance of OSSEOTITEI mplants as compared to other BIOMET3iDental Implants in patients withpoor quality :For safe and effective use of BIOMET3iDental Implants, abutmentsand other surgical and restorative dental accessories, these products or devicesshould only be used by trained professionals.

6 The surgical and restorativetechniques required to properly utilize these devices are highly specialized andcomplex procedures. Improper technique can lead to implant failure, loss ofsupporting bone, restoration fracture, screw loosening and :All dental implants and some abutments are supplied sterile and aresterilized by an appropriate validated method. Refer to individual Product labelsfor sterilization information; all sterile products are labeled STERILE. Allproducts sold sterile are for single use before the expiration date printed on theproduct label. Do not use sterile products if the packaging has been damaged orpreviously opened. Do not re-sterilize or autoclave except where instructions todo so are provided on the Product label, in the Surgical Manual, in theRestorative Manual or in any additional marketing literature for that provided nonsterile must be cleaned and sterilized according to thedirections found inART630or the Surgical Manual prior to Precautions, Surgery:For a detailed explanation of the proceduralprecautions refer to the Surgical the planning phase, it isimportant to determine the vertical dimension, the actual space available betweenthe alveolar crest and the opposing dentition, in order to confirm that theavailable space will accommodate the proposed abutment and the final crownrestoration.

7 This information varies with each patient and abutment; therefore itshould be carefully evaluated before placing any dental implant. The finalprosthesis should be designed prior to the placement of the dental continuous irrigation with a cool, sterile irrigating solution to avoidexcessive damage to the surrounding tissue and to prevent compromisingosseointegration. This is mandatory during all procedures. Avoid excessivepressure during preparation of the bone site. As the drilling speed varies basedon the instrument and the surgical procedure, recommendations for speed canbe found in the Surgical Manual. Only sharp instruments of the highest qualityshould be used for any surgical procedure involving bone. Minimizing trauma tothe bone and surrounding tissue enhances the potential for successfulosseointegration. In order to eliminate contaminants and other sources ofinfection, all non-sterile devices should be cleaned and/or sterilized prior to use,per the instructions on the individual Product Precautions, Restoration:The healing period varies depending onthe quality of the bone at the implantation site, the tissue response to theimplanted device and the surgeon s evaluation of the patient s bone density at thetime of the surgical procedure.

8 Excessive force applied to the dental implantshould be avoided during the healing period. Proper occlusion should beevaluated on the implant restoration to avoid excessive Adverse Events:Potential adverse events associated with the use ofdental implants may include: Federal Law restricts this device to sale by or on the order of a licenseddentist or Of ContentsIntroductionCompany OverviewiProduct Innovations TimelineiiSystem DistinctionsiiiPatient Specific Restorations OverviewvRestorative Products FlowchartCement-Retained Restoration Details1 Screw-Retained Restoration Details1 Provide Abutment Selection Guide2 Restorative ProductsCertain Internal Connection:Cement-Retained RestorationsProvide Abutments3 GingiHue Posts5 ZiReal Posts7 UCLA Abutments9 Screw-Retained RestorationsUCLA Abutments11 IOL Abutments13 Conical Abutments15 OverdentSURE RestorationsDIEM IOL Abutments17 Standard Abutments19 LOCATOR Abutments21 Provisional RestorationsPreFormance Posts23 PreFormance Temporary Cylinders24 External Hex Connection.

9 Cement-Retained RestorationsGingiHue Posts25 ZiReal Posts27 UCLA Abutments29 Screw-Retained RestorationsUCLA Abutments31 IOL Abutments33 Conical Abutments35 OverdentSURE RestorationsDIEM IOL Abutments37 Standard Abutments39 LOCATOR Abutments41O-Ring Abutments43 Dal-Ro Abutments45 Provisional RestorationsPreFormance Posts47 PreFormance Temporary Cylinders48 Miscellaneous Restorative ProductsScrews49 Mechanical Driver Kits51 Drivers And Driver Tips52 Navigator System Instrumentation Overview53 Navigator Laboratory Kit54 Laboratory Tools/Miscellaneous Items55 Professional Development ProductsTools For The Art Of Business Building56 Additional InformationIndex57 Ordering FormOrdering InformationiImplant Innovations Inc.( 3i ) was co-founded in1987 by a periodontist andan engineer. The clinicianbelieved his patientsdeserved better fitting andlooking implant restorationsthan could be accomplishedwith available implantsystems.

10 In 1999, Biomet ,Inc., a leading manufacturerof orthopedic components, order to have greater consistency in the use of the3iBrand, increase global awareness and recognitionof the parent company and leverage the synergy ofconsistent imaging among all Biomet Subsidiaries,3iProducts began selling under the BIOMET3iNameworldwide in 2007. This has greatly enhancedBIOMET3i s Research and Development resourcesand potential for , BIOMET3ioffers one of implant dentistry smost comprehensive lines of implants andabutments, augmented by a growing line of sitepreparation and regenerative products. BIOMET3ipioneered the development of biologically drivenimplants, winning worldwide acclaim for themicrotextured surface and superior clinical successrates of the OSSEOTITE in Palm Beach Gardens, Florida, withoperations throughout the world, BIOMET3iis one ofthe leading companies in the oral reconstructionmarket.