(395 days)
Match Master low fusing porcelain is to be used in conjunction with metal or pressable ceramic framework in the construction of crowns and/or bridgework.
Not Found
This document is a letter from the FDA to Davis Schottlander & Davis Limited regarding their device, Schottlander MATCH MASTER Low Fusing Porcelain. The letter states that the FDA has reviewed the company's premarket notification (510(k)) and determined that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the FDA's regulatory decision regarding market clearance based on substantial equivalence. Therefore, I cannot provide the requested information from 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.