(79 days)
SEcure Adhesive Dental Cement is a dual-cure, self-etching, adhesive dental cement system. It is intended for indirect cementation of porcelain, ceramic, resin, and metalbased inlays, onlays, crowns, bridges, veneers and posts.
SEcure is a dual-cure, self-etching, adhesive dental cement system consisting of a self-etching primer and a two-part dental cement. The self-etching primer is supplied in a single bottle, while the dental cement is supplied in a double-barrel auto-mix syringe. The cement system does not require acid etching of tooth surfaces, and can be cured with any available curing light.
I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a dental cement, focusing on its description, intended use, and substantial equivalence to predicate devices for regulatory approval. It does not include details about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical study report or performance evaluation chapter.
§ 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.