(51 days)
Turkom-Cera fused alumina copings are indicated for use as core structures of an artificial prosthesis, i.e., a three unit bridge, long bridges, full mouth bridges, for partially endentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
The copings are also indicated for use as single crowns that will be cemented to a natural or an artificial tooth abutment in the treatment of partially endentulous patients in order to restore chewing function.
Turkom-Cera (Coping for porcelain teeth)
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the Turkom-Cera device. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It defines the indications for use but does not present any performance study data or acceptance criteria that would typically be associated with such a study.
§ 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.