(86 days)
Argen PEARL brand zirconia is intended for CAD/CAM fabrication of all-ceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
Not Found
Based on the provided text, the document is a 510(k) clearance letter from the FDA for a dental material (Argen PEARL Brand Zirconia), not a study report for an AI/device for diagnostics or prediction. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic devices, is not present in this document.
The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a detailed performance study against specific acceptance criteria.
Therefore, it is not possible to extract the requested information 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.