(13 days)
Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers, crowns and bridges.
Not Found
I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Vitablocs® device, which is a dental restoration material.
This document primarily states that the device has been found substantially equivalent to predicate devices and outlines regulatory requirements. It does not contain any information about specific acceptance criteria, study designs, sample sizes, ground truth establishment, or any performance data of the device itself.
Therefore, I cannot provide the requested information, including the table of acceptance criteria and reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
§ 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.