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The Biodenta Customized Abutment - Titanium is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. The Biodenta Customized Abutment - Titanium is compatible with the following dental implant systems: | Implant Brand, Type | Implant Platform Name: Implant Diameter | |---------------------------------------------------|--------------------------------------------------------------------| | Biodenta, Bone Level and Tapered | B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm | | Nobel Biocare, Nobel Replace straight and tapered | NP: 3.5 mm; RP: 4.3 mm; WP: 5.0 mm; 6.0: 6.0 mm | | Nobel Biocare, NobelActive | NP: 3.5 mm; RP: 4.3, 5.0 mm | | Biomet 3i, Certain Internal | 3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm; 5.0: 5.0, 6.0 mm; 6.0: 6.0 mm | | Dentsply, Astra Tech OsseoSpeed | 3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm | | Straumann, Bone Level | NC: 3.3 mm; RC: 4.1, 4.8 mm | | Zimmer, Screw Vent and Screw Vent Tapered | 3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm | | Biohorizons, Internal straight and tapered | 3.5: 3.5, 3.8 mm; 4.5: 4.0, 4.6 mm; 5.7: 5.0, 6.0, 5.8 mm; | | Osstem (Hiossen), GS and TS | Mini: 3.5 mm; Regular: 4.0, 4.5, 5.0 mm |

Biodenta Customized Abutment - Titanium is a one-piece custom abutment made of titanium. It utilizes an Abutment Screw for abutment retention. The upper portion is designed by a dental technician using CAD software and manufactured at Biodenta milling centers. The final cement retained restoration is constructed in the lab according to the dentist's specifications. The Abutment and the Abutment Screw are made of biocompatible Ti-6AI-4V ELI conforming to ISO 3852-3 and ASTM F136.

The Biodenta Customized Abutment - Hybrid is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. The Biodenta Customized Abutment - Hybrid is compatible with the following dental implant systems: Biodenta, Bone Level and Tapered B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm Nobel Biocare, Nobel Replace straight and tapered NP: 3.5 mm; RP: 4.3 mm; WP: 5.0 mm; 6.0: 6.0 mm Nobel Biocare, NobelActive NP: 3.5 mm; RP: 4.3, 5.0 mm Biomet 3i, Certain Internal 3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm; 5.0: 5.0, 6.0 mm; 6.0: 6.0 mm Dentsply, Astra Tech OsseoSpeed 3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm Straumann, Bone Level NC: 3.3 mm; RC: 4.1, 4.8 mm Zimmer, Screw Vent and Screw Vent Tapered 3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm

The Biodenta Customized Abutment - Hybrid is a two-piece abutment, which contains a premanufactured (stock) Titanium-Base and a Zirconium coping and/or crown that is designed by a dental technician using CAD software and manufactured at Biodenta milling centers. The Biodenta Customized Abutment - Hybrid utilizes an Abutment Screw for abutment retention. The final cement retained restoration is constructed in the lab according to the dentist's specifications. The Biodenta Customized Abutment - Hybrid is compatible with the following dental implant systems: Biomet 3i, Certain Internal; Dentsply, AstraTech OsseoSpeed; Zimmer, Screw Vent; Nobel Biocare, Nobel Biocare, NobelReplace; Straumann, Bone Level; Biodenta, Bone Level and Tapered The Titanium-Base and the Abutment Screw of the Biodenta Customized Abutment - Hybrid are made of biocompatible Ti-6AI-4V ELI conforming to ISO 3852-3 and ASTM F136. The Zirconium coping and/or crown of the Biodenta Customized Abutment - Hybrid are made of biocompatible ZrO2 conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. They are intended for delayed loading.

The Biodenta Dental Implant System - Bone Level Tapered D3.0 and L6.5 mm is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, prosthetic parts and related surgical instruments. The Bone Level Tapered D3.0 and L6.5 mm implants use the same platforms and abutment connections like the Bone Level D 3.0 to 6.0 (K123512). Therefore the abutments and prosthetic parts which are compatible to the Bone Level D 3.0 to 6.0 (K123512) are also compatible to the predicate device. The submission includes: - Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0 - Diameter 4.1, 4.8, and 6,0 mm Implants with Length of: 6.5 mm; Platform B2

Biodenta Dental Implant System Multi Use Abutments are intended for terminal or intermediate abutment support for fixed or removable crown, bridgework and to retain overdentures.

The Biodenta Dental Implant System - Multi-Use Abutment is an extension to the Biodenta Dental Implant System Bone Level (K111003), which is an integrated system of endosseous dental implants, abutments and prosthetic parts and related surgical instruments. The Biodenta Dental Implant System - Multi-Use Abutment includes 0°, 18°, and 30° abutments for screw retained restorations. Each angulation is available with 2, 3, 4, and 5 mm cuff height for both Biodenta Bone Level implant platform types (B1 and B2). The angulated abutments include hexed and non-hexed versions for single unit or multi unit restorations respectively. Abutment diameters are from 4.5 - 5.0 mm. The system includes a ball attachment abutment with a diameter of 4.5 mm and height of 5.5 mm, and temporary abutments with a diameter of 4.0 mm and height of 12.5 mm, which are to be attached onto the Multi-Use Abutment. Burn out cylinders are provided. The system includes 2 diameters of abutment and 1 diameter of prosthetic screws. Short and long impression posts for open and closed tray impression taking, and a protective cap for the Multi-Use Abutment is included.

Biodenta Dental Implant System Abutments are intended for terminal or intermediate abutment support for fixed or removable crown or bridgework.

The Biodenta Dental Implant System Abutments is an extension and compatible to the Biodenta Dental Implant System Bone Level (K111003) which is an integrated system of endosseous dental implants, abutments and prosthetic parts and related surgical instruments. The Biodenta Dental Implant System Abutments includes 3 abutment types: Temporary PEEK abutments are manufactured of biocompatible PEEK plastic and used for temporary restorations for 180 days or less. They are attached to the dental implant using an abutment screw made of titanium alloy. Swift Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Swift Abutments are designed in order that crowns and bridges can be attached by cement retention. Sleeve Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Sleeve abutments are designed in order that bridges can be attached by screw retention. All Abutments are straight abutments.

Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

The Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, prosthetic parts and related surgical instruments. The Bone Level D 3.0 to 6.0 mm implants use the same platforms and abutment connections like the Bone Level implants (K111003) for the diameter 4.1. 4.8. and 6.0 mm implants, and therefore the abutments and prosthetic parts of the Bone Level implants are used. The diameter 3.0 mm implants use the same connection concept in a narrower version. The submission includes: - Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0 - Diameter 4.1 and 4.8 mm Implants with Length of: 6.5 mm; Platform B2 - Diameter 6.0 mm Implants with Length of: 6.5, 8, 10, and 12 mm; Platform B2 - Straight abutments (Straight, Temporary, Ball, Locator); B0 platform, Length 10.4 14.9 mm, Diameter 3.6 - 4.0 mm - Healing abutments, closure screws; B0 platform, Height 0.5 7.1 mm, Diameter 2.8 3.9bmm

Biodenta bone level tapered dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

The Biodenta Dental Implant System - Bone Level Tapered is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants and related surgical instruments. The Bone Level Tapered implants use the same platforms and abutment connections like the Bone Level implants (K111003), and therefore the abutments and prosthetic parts of the Bone Level implants are used with the Bone Level Tapered implants. The System includes dental implants with the following dimensions: - Diameter 3.5 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B1 - Diameter 4.1 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B2 - Diameter 4.8 mm Implants with Length of: 8, 10, 12, and 14 mm; Platform B2 - Diameter 6.0 mm Implants with Length of: 8, 10, and 12 mm; Platform B2

Biodenta bone level dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or intermediate abutment support for fixed or removable bridgework and to retain overdentures.

The Biodenta Dental Implant System - Bone Level is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and prosthetic parts and related surgical instruments.

The Biodenta Customized Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. The Biodenta Customized Abutment is compatible with the following implant systems: -Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Friadent: FRIALIT Implant. XiVA Implant. 3i:Certain Internal Connect Type: Astra: Osseospeed Implant. Osseospeed TX implant; Biohorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System. -Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered, Replace Select Straight; for the NP, RP, WP and 6.0 implants. -External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

Biodenta Customized Abutments are titanium abutments designed to be used in coniunction with specific dental implants utilizing the Biodenta customized abutment screws to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. The abutment is milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry. The abutment is made from titanium grade Ti-6AL-4V ELI (meets ASTM standard F-136). The abutment screw and interface is made from titanium grade Ti-6AL-4V ELI (meets ASTM standard F-136). The Biodenta Customized Abutment is compatible with the following implant systems: -Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Friadent: FRIALIT Implant, XiVA Implant, 3i:Certain Internal Connect Type; Astra: Osseospeed Implant. Osseospeed TX implant: Biohorizons: Internal Implant System. Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System. -Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered. Replace Select Straight; for the NP, RP, WP and 6.0 implants. -External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

Biodenta dental implants intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. Specific indications for small diameter (Ø 3.5 mm) implants: It is recommended not to place small implants with "NP" platform in the molar or premolar region.

The BIODENTA Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.