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BioHorizons implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants. BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored using delayed loading, or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures. BioHorizons Tapered Internal 3.0, Tapered Tissue Level 3.0 Implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion, (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading. Intra-Lock implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants. Intra-Lock 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion, (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading. Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications. Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function. MILO™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function. They are also indicated for the rehabilitation of single maxillary lateral incisors and mandibular lateral incisors. The implants may be restored after a period of time or placed in immediate function. BioHorizons Prosthetics are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters. BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used as straight abutments. The BioHorizons Multi-unit Abutments for CONELOG® are intended to function in the mandble or maxilla to support single and multiple-unit temporary or definitive restorations on CONELOG dental implants. BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm and 5.7mm internal hex-connection mating platform diameters. All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters. Intra-Lock Prosthetics are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with Intra-Lock implants. Intra-Lock Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used as straight abutments. Intra-Lock CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with Intra-lock implants. All digitally designed abutments and/or copings for use with Intra-Lock CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. Intra-Lock abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters. The MILO and Mini Drive Lock Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.

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The BioHorizons Multi-unit Abutments for CONELOG® are intended to function in the mandble or maxilla to support single and multiple-unit temporary or definitive restorations on CONELOG dental implants.

The purpose of this submission is to obtain marketing clearance for BioHorizons Multi-unit Abutments for CONELOG® implants. The submission includes a set of multi-unit abutment screws compatible with two (2) implant lines within the CONELOG® Implant System, manufactured by Altatec GmbH. This compatibility was established via a business agreement between BioHorizons Implant Systems, Inc. and Altatec GmbH. The corresponding compatible CONELOG implant platform diameters range from 3.3 mm to 4.3 mm. All sizes of the compatible CONELOG dental implants have the same tapered implant/abutment interface connection design as the subject device. The connection includes three (3) positioning cams on the abutment that engage complementary features on the implant to prevent rotation of the abutment relative to the implant. The subject device Multi-unit Abutments for CONELOG are designed for attachment of single-unit and multi-unit screw-retained restorations. They are available in straight and angled designs, which are referred to as Multi-unit Straight Abutment for CONELOG and Multi-unit Angled Abutment for CONELOG, respectively. The straight and angled designs each are available in gingival heights of 2, 3, and 4 mm. All designs have a prosthetic diameter of 4.8 mm. Multi-unit Angled Abutment for CONELOG designs have the coronal end inclined at either 17° or 30° to the implant axis for correction of angulation. The angled abutment includes an internal thread in the coronal portion of the abutment to accommodate a prosthetic screw for the screw-retained restoration. Each angled abutment is available in Type A or Type B orientations. Type A refers to an orientation in which one (1) of the three (3) positioning cams is aligned opposite the direction of abutment angulation. Type B refers to an orientation in which the cam alignment coincides with the direction of abutment angulation. The subject device Multi-unit Abutments for CONELOG includes Class II abutment-level prosthetic components used for fabrication of provisional and final restorations. These prosthetic components include copings made of titanium alloy, gold alloy, or polyoxymethylene, a temporary cover cap made of titanium alloy, and prosthetic screws made of titanium alloy. The titanium alloy and gold copings and the prosthetic screws become part of the finished restoration. All subject device abutments and abutment screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

BioHorizons Tapered IM Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

The BioHorizons Tapered IM Implants are machined titanium, screw-form endosseous dental implants supplied in 7.0mm and 8.0mm diameters. Both implants include a 5.7mm prosthetic platform. The implants are provided in 7.5mm, 9.0mm and 10.5mm lengths across both diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surqical Implant Applications. The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (hydroxylapatite) and by micro-machining grooves, known as Laser-Loke microchannels, on the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

BioHorizons CAD/CAM Bars are intended for use as superstructures of a multiple-unit endosseous dental implant system, attaching directly to implants or abutments, to support a prosthetic device in a partially or fully endentulous patient for the purpose of restoring chewing function. Implant-level bars are compatible with all BioHorizons Internal and Tapered Internal implant systems. Implant-level bars are compatible with Zimmer Dental Screw-Vent® and Tapered Screw Vent® implants with 3.5mm, 4.5mm internal hex connection mating platform diameters and are intended to be used with straight bar cylinders only. Abutment-level bars are compatible with BioHorizons Multi-unit Abutments. All digitally designed BioHorizons CAD/CAM Bars are intended to be sent to a BioHorizons-validated milling center for manufacture.

The BioHorizons CAD/CAM Bars are computer aided designed (CAD), precision computer aided milled (CAM) superstructures manufactured for individual patients. The BioHorizons CAD/CAM Bars provide support for a fixed or removable prosthetic device. The BioHorizons CAD/CAM Bars will be provided in a fixed shape configuration (e.g. Dolder®, Hader, Round) or a free form shape configuration (e.g. Freeform/Milled, Hybrid, Montreal, Paris, Wrap Around), both configurations designed to fit the individual needs of the patient. The BioHorizons CAD/CAM Bars will be provided with either an implant-level or abutment-level connection interface. Implant-level CAD/CAM bars will include passive, non-indexing connection geometry with seating on the coronal (top) surface of the implant. Abutment-level CAD/CAM bars will include passive, non-indexing connection geometry with seating on the restorative platform of the abutment. The occlusal surface of the CAD/CAM bars may include connection geometry (e.g. female threads) to accept overdenture attachments. Bar material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications. The CAD/CAM Bars are provided non-sterile, and they are packaged using materials known in the industry to be appropriate for medical device packaging. When used with BioHorizons Internal and Tapered Internal implant systems, the BioHorizons CAD/CAM bars allow for up to 40° divergence between bar cylinders, with no individual bar cylinder angulated greater than 20° from the vertical axis. Only straight bar cylinders are compatible with the Zimmer Dent® and Tapered Screw Vent® implants with 3.5mm. 4.5mm and 5.7mm internal hex connection mating platform diameters.

BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored using delayed loading, or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures.

The BioHorizons Tapered Short Implants are machined titanium, screw-form endosseous dental implants supplied in 4.6mm and 5.8mm diameters. The 4.6mm diameter implant includes a 3.5mm prosthetic platform, while the 5.8mm diameter implant includes a 4.5mm prosthetic platform. The implants are provided in 6.0mm and 7.5mm lengths across both diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov (UNS R56401) for Surgical Implant Applications. The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser-Lok® microchannels, on the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters. All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.

BioHorizons CAD/CAM Abutments are dental implant final restorative abutments supplied in platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm. The abutments are intended to provide support for dental prosthetic restorations. Each abutment includes an abutment screw for fixation to the underlying implant. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications. Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified region of the abutment margin. The abutments are provided non-sterile, and they are packaged using materials known in the industry to be appropriate for medical device packaging.

BioHorizons Tapered Internal Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

The BioHorizons Tapered Internal Implants are machined titanium, screw-form endosseous dental implants supplied in 3.4mm and 4.6mm diameters. The 3.4mm diameter implant includes lengths of 9mm, 10.5mm, 15mm and 18mm while the 3.8mm and 4.6mm diameter implants include an 18mm length option to complement currently cleared implant lengths within those implant body diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications. The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser• Lok® microchannels, to the implant collar of select models. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10-6, validated in compliance with ANSVAAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part I: Requirements for development, validation and routine control of a sterilization process for medical devices.

BioHorizons Tapered Internal Plus Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

BioHorizons Tapered Internal Plus Implants are machined titanium, screw-form endosseous dental implants supplied in 3.8mm, 4.6mm and 5.8mm diameters across lengths of 7.5mm (except 3.8mm diameter), 9mm, 12mm and 15mm. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov (UNS R56401) for Surgical Implant Applications. The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser-Lok® microchannels, to the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

BioHorizons Laser-Lok Abutments for Nobel Biocare™ are intended for use with dental implants as a support for single or multiple unit prostheses in the maxilla or mandible of partially or fully edentulous patients. The abutments are compatible for use with Nobel Biocare™ NobelReplace™ Straight Groovy™, NobelReplace™ Tapered Groovy™, NobelSpeedy™ Replace™, Replace™ Select Tapered and Replace™ Select Straight implants with 3.5mm (NP), 4.3mm (RP) and 5.0mm (WP) platform diameter internal trichannel connections. The abutment screw is intended to secure the abutment to the endosseous implant. BioHorizons Laser-Lok Titanium Base Abutments for Nobel are intended to be used as straight abutments.

BioHorizons Laser-Lok Abutments for Nobel Biocare™ are a series of machined titanium endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.3mm and 5.0mm which are compatible with the internal trichannel connection of Nobel Biocare™ endosseous dental implants. The series includes Simple Solutions Abutments, Custom Titanium Abutments and Titanium Base Abutments. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The devices are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. The product is packaged using materials known in the industry to be appropriate for medical device packaging. Devices labeled 'STERILE' are provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

BioHorizons Abutments for Zimmer® are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The contouring tissue and final rootena.vo and restoration and are compatible for abuthents may be assurfor a Single of the nal implant systems and Zimmer use with Blondons internal and Tapered Screw-Vent® implants with 3.5mm and 5.7mm internal hex-connection mating platform diameters. BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used to be used as straight abutments.

BioHorizons Abutments for Zimmer are comprised of endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.5mm and 5.7mm. Abutment materials are titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), zirconia ceramic as specified in ISO 13356 Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP), Gold Alloy 6019 and PEEK as specified in ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications (temporary abutments only). Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. Abutments provided sterile are packaged using materials known in the industry to be appropriate for medical device packaging and are provided with a minimum sterility assurance level of 108, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ANSI/AAMI/ISO 11137-2 Sterilization of healthcare products -- Radiation -- Part 2: Establishing the sterilization dose.