(184 days)
Fabrication of all ceramic restorations except for four- or more unit bridges including molars.
Not Found
I'm sorry, but this document does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a dental product called "Vintage Prime Press," which is a porcelain powder for clinical use. It outlines the regulatory clearance process and the indications for use of this device.
The document does not describe acceptance criteria for a device's performance, nor does it detail a study that proves the device meets such criteria. It discusses the regulatory path, product classification, and general controls applicable to the device.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, information about sample sizes or data provenance for a test set, details on expert roles for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.