(283 days)
TEMPORARY CEMENT FOR DENTAL USE ONLY.
Not Found
Given the provided text, none of the requested information regarding acceptance criteria or a study proving a device meets those criteria is present. The document is an FDA 510(k) clearance letter for a device called "Provi Cement," indicating that it has been found substantially equivalent to a legally marketed predicate device. This letter does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested table or answer questions 2 through 9 based on the given input.
§ 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.