(108 days)
Avante® Z is an all-ceramic dental restoration system used by a trained dental technician in a dental laboratory to create crowns (anterior and posterior), inlays, onlays, and veneers, with or without Zirconium Oxide (ZrO2) cores.
Avante® Z is an all-ceramic dental restoration system
This document is a 510(k) clearance letter from the FDA for a dental restoration system. It does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot fulfill your request based on the provided text. The document primarily discusses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the technical studies or performance metrics used to reach that conclusion.
§ 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.