(90 days)
For cementing dental posts inside prepared postholes, prior to rebuilding the missing coronal tooth structure.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental cement product called "Sci-Pharm Post Secure." It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
Crucially, this document is a regulatory approval letter and does not contain any information about acceptance criteria, study data, or performance metrics for the device. It's a notification of clearance, not a summary of a clinical or performance study.
Therefore, I cannot provide the requested information based on the provided text. The document states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device" and "determined the device is substantially equivalent." This determination is based on the information provided by the manufacturer in their 510(k) submission, which would include performance data, but that data itself is not present in this letter.
§ 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.