(531 days)
DIAZIR Zirconia Dental Ceramics are indicated for the use of artificial teeth production for either fixed or removable dentures, or for jacket crowns, facings, veneers as well as bridge up to three units.
Not Found
I am sorry, but the provided document is a letter from the FDA regarding a 510(k) premarket notification for "DIAZIR Zirconia Dental Ceramics." It focuses on regulatory approval and general information rather than detailing specific acceptance criteria for performance, a study proving those criteria were met, or any of the technical specifics of a study about device performance.
Therefore, I cannot extract any of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies from this document.
§ 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.