(88 days)
A temporary cement for fixing dental bridges, temporary crowns or bridges, and all metal, porcelain and acrylic crowns.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Fixobridge 3-Cement" device. It primarily discusses the substantial equivalence of this dental cement to legally marketed predicate devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence, not on specific performance studies with acceptance criteria.
§ 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.