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BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. OSSEOTITE® 2 Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

OSSEOTITE® 2 Dental Implants are similar to predicate BIOMET 3i OSSEOTITE Implants, currently being sold worldwide. OSSEOTITE 2® Dental Implants are provided with the proprietary OSSEOTITE dual acid-etched surface which has been in commercial distribution since market clearance in 1995 and are made of Commercially Pure Titanium. Implants have a straight wall design, with an External Hex Connection. OSSEOTITE® 2 Dental Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 3 mm to 15 mm. Size appropriate cover screws are provided with each implant.

BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.

BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection can be compared to current Encode Patient Specific abutments. The change to this device is only to the connection that is intended to interface which is identical to the interface found on the Nobel Replace HA Coated Implant. This feature does not modify the intended functionality of the implant/abutment system. This device is also intended for dental laboratories to provide limited design input to match the anatomical requirements of the patient. Maximum angulation for the abutment is limited to 15°.

BIOMET 3i Dental Implants are intended for surgical placement in either jaw and used for anchoring or supporting single- and multiple-unit prostheses. BIOMET 3i Dental Implants can be immediately loaded when primary stability and proper occlusion have been established.

Full OSSEOTITE® Certain® II Dental Implants are substantially equivalent to BIOMET 3i's OSSEOTITE® Dental Implants which have been previously cleared in K063286 and K063341. The device is an endosseous dental implant made of Commercially Pure Titanium. It is available in various lengths and diameters with a straight-walled implant body, Incremental Cutting Edge (I.C.E.) with apical taper, and a Full OSSEOTITE® surface. It has an Internal Hexagon Connection for mating with BIOMET 3i Certain® Restorative Components. The implants are packaged in a sterile tray with a cover screw and sterilized by Gamma Irradiation with a shelf life of 5 years.

Encode® Patient Specific Dental Abutments made from oral scans provided from Sirona CEREC AC Scanner System and inLab Software v3.65 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Encode® Patient Specific Dental Abutments are designed specifically for a patient using a CAD/CAM system. The abutments are designed from a threedimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which are derived from the scan. The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows: | Description | Min. | Max. | |----------------------------------------------------------------------|---------|--------| | A.) Platform Seating Diameter | 3.4 mm | 6.0mm | | B.) Gingival Margin Diameter | 3.8mm | 16.0mm | | C.) Gingival Margin Height External<br>Hex 3.4mm Platform | 0.5 mm | N/A | | C.) Gingival Margin Height Certain<br>3.4mm Platform | 0.25 mm | N/A | | C.) Gingival Margin Height<br>4.1mm/5mm/6mm<br>External Hex /Certain | 0.25 mm | N/A | | D.) Total Height | 4.75mm | 15.0mm | | E.) Angulations | 0° | 30° |

Encode® Patient Specific Dental Abutments made from oral scans provided from 3M ESPE Lava Chair Scanner and the 3M Lava COS (2.0) software are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Patient Specific Dental Abutments are Encode® designed specifically for a patient using a CAD/CAM system. The abutments are designed from a threedimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which are derived from the scan. The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows: | Description | Min. | Max. | |----------------------------------------------------------------------|---------|--------| | A.) Platform Seating Diameter | 3.4 mm | 6.0mm | | B.) Gingival Margin Diameter | 3.8mm | 16.0mm | | C.) Gingival Margin Height External<br>Hex 3.4mm Platform | 0.5 mm | N/A | | C.) Gingival Margin Height Certain<br>3.4mm Platform | 0.25 mm | N/A | | C.) Gingival Margin Height<br>4.1mm/5mm/6mm<br>External Hex /Certain | 0.25 mm | N/A | | D.) Total Height | 4.75mm | 15.0mm | | E.) Angulations | 0° | 30° |

BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Encode® Abutments are designed specifically for a patient in a CAD/CAM system. The abutments are designed from a three-dimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which is derived from the scan. The abutments are manufactured from titanium alloy or ceramic.

The 3i Patient-Specific CAM StructSURE® Precision Milled Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient.

All CAM StructSURE® Precision Milled Bars (Dolder, Primary, Hader, Hybrid and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then machined using a CAD/CAM software system. The bars are milled from either titanium alloy or CP titanium.

BIOMET 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is screw retained to the abutment.

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The CAM StructSURE® Precision Milled Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

All CAM StructSURE® Precision Milled Bars (Dolder, Primary, Hader, Hybrid and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then is machined using a CADCAM software system. The bars are milled from titanium alloy or CP titanium. CAM StructSURE® Precision Milled Bars: CSHxx CAM StructSURE Hader Bar: 2-10 implants CSPxx CAM StructSURE Primary Bar: 2-10 implants CSDxx CAM StructSURE Dolder Bar: 2-10 implants CSCMxx CAM StructSURE Copy Milled Bar: 4-10 implants CSIYxx CAM StructSURE Hybrid Bar: 4-10 implants

BIOMET 31 Certain® Contoured Margin Ceramic Abutments are intended for use as an cessory to endosseous dental implants to support a prosthetic device in a partially or contains patient. The Certain® Contoured Margin Ceramic Abutments are intended for use support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis is ment retained to the abutment.

The BIOMET 3i Certain® Contoured Margin Ceramic Abutment design consists of The BIOME I 37 Certains Contoured in buttent screw. These devices worldwords ffferent abutments $125, thanimi insort and all about - 11.00 as 1000 as 1000 and and propriate reatures and 311 with internal connections.