(105 days)
VINTAGE MP is paste or powder porcelain intended to fabricate metal-ceramic restorations. It is used in conjunction with precious alloys for metal-ceramic restoration, metals for metal-ceramic restoration and stain materials for metalceramic restoration in order to produce natural looking restorations and prostheses.
VINTAGE MP is paste or powder porcelain
This document is an FDA 510(k) clearance letter for a dental porcelain product, "Vintage MP." It is not a study report and therefore does not contain the information requested regarding acceptance criteria and device performance studies.
The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. It outlines regulatory requirements for marketing the device but does not include any performance data or study details.
To answer your questions, one would need to refer to the actual 510(k) submission document, which is not provided here.
§ 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.