(50 days)
Intended Use: Protec Cem is intended to be used with crowns and bridges constructed of Targis/Vectris material on conventionally prepared stumps with adequate mechanical retention. Cementation of metal or Porcelain Fused to Metal (PFM) inlays, partial crowns, crowns, bridges, as well as metal root canal posts, metal post build ups, and orthodontic bands.
Protec Cem
I cannot answer the question based on the provided document because the document is a 510(k) clearance letter from the FDA, and it does not contain the detailed information about acceptance criteria, study design, or performance metrics requested in the prompt. It only states that the device, Protec Cem, has been found substantially equivalent to a legally marketed predicate device. The prompt asks for specifics about acceptance criteria and study data that are not present in this regulatory correspondence.
§ 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.