(172 days)
Permanent extraoral and intraoral luting of superstructures (incl. Mesostructures) made of metal, ceramics, zirconium dioxide and polymers (composite, hybrid ceramics or PMMA) on prefabricated adhesive/titanium bases (extraorally only), on customized titanium and zirconium dioxide bases (both extraorally and intraorally) as well as on dental hard tissue.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Bifix Hybrid Abutment Cement." It acknowledges the device's substantial equivalence to predicate devices and outlines regulatory requirements. However, this document does NOT contain information about acceptance criteria or a study proving that a device meets those criteria.
This document is a regulatory clearance letter for a dental cement, not a medical device that uses AI or requires performance metrics for an algorithm. Therefore, the requested information (acceptance criteria, device performance table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for the training set) is not applicable and not available within the provided text.
§ 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.