(105 days)
Shade adjustment of Lithium disilicate and ceramic restorations
Not Found
The provided document is an FDA clearance letter for a dental device (porcelain powder) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It discusses the device's substantial equivalence to other legally marketed devices but does not detail performance metrics, study designs, or effectiveness. Therefore, I cannot 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.