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Bifix QM is intended for adhesive luting of inlays, onlays, facettes, veneers, crowns, partial crowns, pins, posts, bridges and adhesive bridges (Maryland bridges).

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This document is a 510(k) clearance letter from the FDA for a dental cement product called "Bifix QM." It states that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not include details about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the full 510(k) summary or the manufacturer's technical documentation, not in the clearance letter itself.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text. The document is administrative, confirming regulatory clearance, but lacks the technical details of a performance study.

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