(137 days)
Build up porcelain for fabrication of all ceramic restorations including lithium disilicate
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental porcelain powder product (VINTAGE LD). It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The document is purely an administrative letter stating that the FDA has reviewed the submission and determined substantial equivalence to legally marketed predicate devices, allowing the manufacturer to market the device. It also includes the "Indications for Use" for the VINTAGE LD product, stating it is a "Build up porcelain for fabrication of all ceramic restorations including lithium disilicate."
Therefore, I cannot provide the requested table and study details based on the given text.
§ 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.