(75 days)
Pulpdent ResiLute IITM is a radiopaque, resin cement for the permanent cementation of dental inlays, crowns, bridges, veneers, posts, periodontal splints and for bonded amalgam techniques.
Pulpdent ResiLute IITM is a radiopaque, resin cement... It is supplied as a chemical-cure or dual-cure two-paste system (base and catalyst), with and without fluoride, that mixes easily, and as a single light-cured paste, also with and without fluoride. Pulpdent ResiLute II™ has a very low film thickness and bonds to enamel, dentin, metals and ceramic.
The provided document is a 510(k) summary for a dental resin cement, Pulpdent ResiLute II™. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
Therefore, I cannot extract the requested information as it is not present in 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.