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The BASIC Dental Implant System Straight 2-Piece Post and Core Attachment is indicated for attaching artificial teeth to a dental implant.

The Straight Post and Core II Attachment is a three-piece attachment. The top is attached to the base with a hex screw. The base is cemented into a dental implant. Artificial teeth are then attached to the Straight Post and Core II using conventional techniques.

The provided document is a 510(k) summary for the BASIC Dental Implant System Straight Post and Core II Attachment, which is an accessory to a dental implant. It states that no performance data or clinical studies were conducted for this device, as it was deemed substantially equivalent to an existing device (BASIC Dental Implant System 2-Piece Post and Core Attachment K number K001259).

Therefore, it is not possible to provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or ground truth types, as these are typically derived from formal performance studies which were not performed for this 510(k) submission.

The document indicates that the determination of substantial equivalence was based on a comparison to a predicate device already on the market, implying that the new device shares similar technological characteristics and intended use, and therefore is presumed to meet the same safety and effectiveness standards without requiring new performance studies.

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