(36 days)
For temporary or permanent cementation of crowns and bridges on non-vital and vital teeth where retention is of primary concern. Also for use as temporary filling material.
Carbocem Zinc Polycarboxylate Cement
This document is a 510(k) clearance letter from the FDA for a dental cement called Carbocem. It does not contain information about acceptance criteria or a study proving device performance in the context of the questions asked. The questions appear to be geared towards AI/ML device evaluations, which is not applicable to this traditional medical device clearance.
Therefore, I cannot provide the requested information based on 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.