(38 days)
A vante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations.
Avante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations. The composition of Avante Porcelain is similar to that of Synspar Porcelain, K910303. The composition of Available of Avante was adjusted in Avante Porcelain to result in a lower firing temperature compared to Synspar. However, the actual list of chemical compounds present in Avante is similar to that of Synspar.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document describes a 510(k) submission for a dental restorative system (Avante Micro Crystal System) and its substantial equivalence to a predicate device (Synspar Porcelain). It mentions that cytotoxicity testing was not performed due to the similarity in composition to other products on the market and that the lower firing temperature of Avante has no effect on the safety and effectiveness of the material if properly fired.
The document is a 510(k) summary and an FDA clearance letter, which focuses on regulatory approval based on substantial equivalence rather than detailed performance study results with specific acceptance criteria.
§ 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.