(134 days)
Zeramic Adhesive Resin Cement is a prescription only, dual cured, radiopaque resin cement intended to be used for cementation of porcelain, ceramic, resin, metal-based inlays/onlays, crowns, bridges, core build up material, posts and veneers. It is also used for cementation of crown restorations to implants.
Not Found
The FDA letter provided refers to the Zeramic Adhesive Resin Cement (K150601). While it mentions general regulatory information, it does not contain details about specific acceptance criteria or the studies performed to demonstrate the device meets these criteria.
The letter is a notification of substantial equivalence based on a 510(k) submission, meaning the FDA determined the device is as safe and effective as a legally marketed predicate device. The information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies would typically be found within the 510(k) summary or the full 510(k) submission document itself, which are not included in the provided text.
Therefore, I cannot provide the requested information based solely on the provided document. The document primarily focuses on regulatory approval and classification rather than the technical details of device performance testing.
§ 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.