(24 days)
Class I and II restorations in deciduous teeth Non-load bearing Class I and II restorations in permanent teeth Immediate restorative and base material for heavy stress situation in Class I and II cavities using sandwich laminate technique Class V and root surface restorations Core build up
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to GC America, Incorporated for a dental cement called "GC Fuji IX GP EXTRA". This document is a regulatory approval and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria as typically found in a clinical trial report or scientific publication for AI/ML devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details. This document is a regulatory approval and does not describe technical performance metrics or how they were tested.
§ 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.