(29 days)
Bifix QM is intended for adhesive luting of inlays, onlays, facettes, veneers, crowns, partial crowns, pins, posts, bridges and adhesive bridges (Maryland bridges).
Not Found
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.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.