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The T3® Pro 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 loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. The T3® Pro Implants may also utilize immediate loading for these indications. The T3® Pro 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.

The T3® Pro Implants with the new ZimVie Implant Packaging System. The material and design of the subject device is identical to the primary predicate device T3® Pro Implants cleared in K213672. The ZimVie Implant Packaging System configuration, similarly to the primary predicate device, consists of a titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed in a heat-sealed outer tray, covered with a Tyvek® lid. The outer tray is placed inside a cardboard box, and gamma sterilized. The new ZimVie Packaging System has been standardized to align the packaging across all ZimVie implant families. The subject device in the new ZimVie Packaging System has a shelf-life of two (2) years.

Immediate Molar 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 loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar 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. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems: | Abutment System Name | Models | Platform Diameters | |-------------------------------------------------|--------------------|--------------------| | Abutments manufactured by<br>Terrats Medical SL | Titanium Abutments | 4.1, 5.0 and 5.7mm | | Abutments manufactured by<br>Zfx GmbH | Titanium Abutments | 4.1, 5.0 and 5.7mm |

The Immediate Molar Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the Immediate Molar Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components and also a TSV connection for mating with associated Zimmer Dental TSV connection restorative components. The implants are also compatible with titanium abutments manufactured by Terrats Medical SL and Zfx GmbH. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy. The T3 PRO Immediate Molar Implants are offered in 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7, 8 and 9mm. The TSX Immediate Molar Implants are offered in 6, 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7 and 8mm. The TSX Immediate Molar Implants are offered in 8, 10 and 11.5mm lengths for implant body diameter size of 9mm.

The BellaTek Bars are indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The BellaTek Bars are intended for attachment to a minimum of two (2) abutments. All digitally designed BellaTek Bars are intended to be sent to Biomet 3i for manufacture. The BellaTek Bars are indicated for compatibility with the following abutment systems: · Universal Multi-Unit Abutments manufactured by Terrats Medical SL., 2.9-5.7mm, Angled, max 30 degrees - · ZimVie Eztetic Implant System - · ZimVie TSX Implant System - · ZimVie Tapered Screw-Vent System - · ZimVie Low Profile Abutments, 3.4-6.0mm, Angled, max 30 degrees - · ZimVie Osseotite Implant System - ZimVie T3 and T3 PRO Implant System - · ZimVie Tapered Abutments, 3.5-5.7mm, Angled, max 30 degrees - · ZimVie TSX Implant System - · ZimVie Tapered Screw-Vent Implant System .

The BellaTek Bars are intended to disperse the load of a prosthesis across dental implant-abutment assemblies. They also provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The subject devices are identical to the reference predicate device CAM StructSURE Precision Milled Bars cleared in K080864 (SE 07/21/2008) with the only addition of the new connection geometry. The subject device has a new bar-to-abutment connection tailored to the multi-unit restorative abutment component(s) with which the device is intended to be used. Similar to the primary predicate device (K233083), the BellaTek Bars are manufactured out of commercially pure titanium per ASTM F67 or Titanium Alloy per ASTM F136. The BellaTek Bars are placed in a nylon bag and sealed in same manner as the reference predicate device (K080864). A label is applied to the bag. Like the primary predicate device (K233083), the BellaTek Bars are offered in two types. A Type I Bar is a Titanium Alloy bar designed for use with removable overdentures. A Type II Bar is a Pure Titanium or Titanium Alloy bar designed for fixed prosthesis. All BellaTek Bars (Dolder, Primary, Hader, Hybrid, Freeform, Canada, Wraparound 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 CAD/CAM software system in accordance with customer specifications, within the limits of design defined in tables below. The subject devices are provided non-sterile in same manner as the predicate devices.

The TSX Implants are designed for use in the maxilla or mandible for immediate loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical) and provide good primary stability. The 3.1mmD TSX Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

TSX Dental Implants are manufactured from biocompatible titanium alloy. TSX Dental Implants surface consists of a Contemporary Hybrid Surface Treatment (Dual Acid Etch + MTX™ Textured Surface). The implants are available in different platform diameters and feature an internal hex connection for mating with associated Zimmer Dental and Biomet 3i internal connection restorative components. For specific product descriptions, please refer to individual product labels.

The T3 Pro 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 loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. The T3 Pro Implants may also utilize immediate loading for these indications. The T3 Pro 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.

The T3 Pro Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the T3 Pro Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy.

The BellaTek Encode Emergence Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.

The BellaTek Encode Emergence Healing Abutment is a two-piece healing abutment (abutment with a retaining screw) designed to facilitate gingival tissue healing before a final restoration is placed. It consists of an abutment and a retaining screw that are assembled and packaged together and provided sterile. Both components are machined from Titanium Alloy Ti-6Al-4V ELI (ASTM F136). They are available in pre-defined diameters, emergence profiles and heights to accommodate varying patient anatomies. The shelf life of the TSV BellaTek Encode Healing Abutment is 5 years from the date of manufacture and they are intended for single use only. The device is packaged in a blister tray with Tyvek Lid and sold sterile. The device is sterilized using the gamma irradiation method. The BellaTek Encode Emergence Healing Abutments are color anodized for aesthetic purposes.

TSV BellaTek® Express and BellaTek® Flex 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. All digitally designed superstructures and/or hybrid abutment crowns for use with TSV BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

The TSV BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. TSV BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Zimmer Dental's Tapered Screw-Vent, Screw-Vent and Trabecular Metal dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and non-hexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile. The TSV Titanium ASC screw used with the subject device is also machined from Titanium Alloy and anodized pink. The device is packaged individually in a sealed nylon bag and sold sterile. When the TSV BellaTek Express or BellaTek Flex Abutment is placed on the corresponding implant, the retaining screw will mate with the internal thread feature of the dental implant to hold the abutment in place.

Certain BellaTek® Express and BellaTek® Flex 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. All digitally designed superstructures and/or hybrid abutment crowns for use with Certain BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

The Certain BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. Certain BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Biomet 3i Certain (Internal Hex) dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and nonhexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.

The TSV™ BellaTek® Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.

The purpose of this submission is to obtain 510(k) premarket clearance for the TSVIM BellaTek® Encode® Healing Abutments compatible with Tapered Screw-Vent® and Trabecular Metal implant systems. Abutments sizing is based on implant platform diameter. TSV™ BellaTek® Encode® Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined markings for identification when taking an abutment level impression or an intraoral scan/digital impression. The occlusal surface of the device include markings that provide information about the mating implant's position and orientation. The principal of operation and Encode "Coding Scheme of the same as the primary predicate device. The pattern of the markings for the subject device is specific to the Tapered Screw-Vent", and Trabecular Metal implant lines.

The Eztetic™ BellaTek® Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.

The Eztetic™ BellaTek® Encode® Healing Abutment is a healing abutment designed to facilitate gingival tissue healing. It consists of an abutment and a retaining screw that are assembled together. Both components are machined from Titanium Alloy (Ti-6AL-4V ELI). The shelf life of the Eztetic™ BellaTek® Encode® Healing Abutment is 5 years and they are intended for single use only. The device is packaged in a sealed nylon bag and sold sterile. The device is sterilized using gamma irradiation method.