(159 days)
DYRACT® CEM PLUS CEMENT is indicated for: 1) Cementation of conventional metal or porcelain-fused-to-metal inlays, crowns, bridges, posts and post-core units: 2) Adhesive cementation of porcelain, composite, or all-ceranic inlays, onlays and crowns; and 3) Cementation of all-zirconia bridges.
DYRACT® CEM PLUS CEMENT is a dental luting cement (powder/liquid system) that combines the major benefits of glass ionomer cements--adhesion to tooth substance and fluoride release--with the mechanical strength of a luting composite.
The provided text is related to a 510(k) premarket notification for a dental luting cement called DYRACT® CEM PLUS CEMENT. It establishes substantial equivalence to predicate devices and outlines the intended uses and technological characteristics. However, it does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert involvement, or any form of clinical or performance study details relevant to the questions asked.
Therefore, I cannot extract the requested information from the provided text. The document is primarily an FDA communication approving market access based on substantial equivalence, not a detailed study report.
§ 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.