(48 days)
Alumina-Zinc Oxide Powders F and R are intended for use with a Eugenol and 2-Ethoxybenzoic Acid Liquid Mixture as a temporary or permanent cement, or as a base or liner in a dental restoration.
Alumina-Zinc Oxide Powders F and R
I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving the device meets those criteria. The text is a letter from the FDA to a medical device company regarding the clearance of their device, "Alumina-Zinc Oxide Powders F and R," through the 510(k) pathway. It confirms substantial equivalence to a predicate device and outlines regulatory responsibilities. It does not contain details about specific performance metrics, study designs, or results.
§ 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.