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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 provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device (TSV™ BellaTek® Encode® Healing Abutments) demonstrating substantial equivalence to a predicate device.

The document explicitly states: "No clinical data were included in this submission." and relies on non-clinical testing data and equivalence to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert opinions, or MRMC studies, as this information is not present in the provided text.

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