(56 days)
Pulpdent DenTASTIC UNO is a single component dental adhesive primer and bond enhancer used by the dental professional to bond to dentin, enamel, metals and resins.
Pulpdent DenTASTIC UNO is a single component dental adhesive primer and bond enhancer used by the dental professional to bond to dentin, enamel, metals and resins. The formula for Pulpdent DenTASTIC UNO is similar to that for Pulpdent Bond Enhancer [K926074. K931710. K953272. K953301] which was developed by the American Dental Association Health Foundation. The products are manufactured under license from that organization.
This request cannot be fulfilled as the provided document {0} - {3} does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) submission summary for a dental adhesive, focusing on its substantial equivalence to predicate devices and general safety information, not specific performance metrics or clinical study details as requested.
§ 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.