(61 days)
For permanent cementation of Crowns and bridges on non-vital teeth and on vital teeth where the use of Conventional Zinc Phosphate Cements is judged appropriate.
ZinFos Zinc Phosphate Cement
The provided document is a 510(k) clearance letter for a medical device called "ZinFos Zinc Phosphate Cement." This document is not a study report and therefore does not contain the information requested in the prompt.
The prompt asks for details about acceptance criteria and a study proving device performance, typically found in a clinical or performance assessment report for a device, especially for those involving AI or diagnostic capabilities. The ZinFos Zinc Phosphate Cement is a traditional dental cement, and its regulatory clearance would be based on substantial equivalence to predicate devices, rather than a performance study as described in the prompt's questions.
Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, or ground truth details from the given text.
§ 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.