(85 days)
A radiopaque, self-cure, resin-based temporary cement that is used to lute provisional restorations such as crowns, inlays, onlays, fixed bridges, laminate veneers, etc. or to temporarily cement permanent dental restorations.
A resin-based cement designed for use with provisional restorations such as crowns, inlays, fixed bridges, etc. or for temporary cementation of permanent restorations.
A radiopaque, self-cure, resin-based temporary cement
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth.
The document is a 510(k) summary for a dental temporary cement, outlining its intended use, classification, and substantial equivalence to predicate devices. It does not contain details about specific performance metrics or clinical study results.
§ 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.