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The abutment submitted is for use in multiple unit, partial, or full edentulous case types. The underlying surface mates with the external hex of the dental implant, and the set screw down the middle locks it into place. Its purpose is to provide a gentle contain of more ing from the top of the implant into the oral cavity, ending with a metal margin or a cosmetic margin that can be established at the laboratory phase. The laboratory technician with this abutment has coping devices to place over the abutment or the abutment analog to fabricate the prosthetic design in the laboratory, which will then be brought to the patient for these clinical indications. It is not intended for single-tooth application, as there is no built-in, anti-rotational features. It is, therefore, recommended only as a multiple unit; partially edentulous; or a multiple unit, totally edentulous abutment design. It functions similarly to other designs in this implant system for similar indications. The components are made of biocompatible ASTM standard titanium/titanium alloy, and it is not considered an implant, as is an abutment piece placed above the top of the implants.

The abutment submitted is for use in multiple unit, partial, or full edentulous case types. The underlying surface mates with the external hex of the dental implant, and the set screw down the middle locks it into place. Its purpose is to provide a gentle contain of more ing from the top of the implant into the oral cavity, ending with a metal margin or a cosmetic margin that can be established at the laboratory phase. The laboratory technician with this abutment has coping devices to place over the abutment or the abutment analog to fabricate the prosthetic design in the laboratory, which will then be brought to the patient for these clinical indications. It is not intended for single-tooth application, as there is no built-in, anti-rotational features. It is, therefore, recommended only as a multiple unit; partially edentulous; or a multiple unit, totally edentulous abutment design. It functions similarly to other designs in this implant system for similar indications. The components are made of biocompatible ASTM standard titanium/titanium alloy, and it is not considered an implant, as is an abutment piece placed above the top of the implants.

I am sorry, but the provided text is a letter about a 510(k) clearance for a dental abutment and does not contain information about acceptance criteria or a study proving its performance. The document focuses on regulatory approval rather than technical performance data. Therefore, I cannot extract the requested information.

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