(262 days)
VINTAGE MP PRESS OVER is used to fabricate Press-To-Metal crowns and bridges.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a dental product called "VINTAGE MP PRESS OVER." This document confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria.
The letter focuses on regulatory approval based on "substantial equivalence" and does not describe a performance study or its results in detail. It does not provide information on acceptance criteria for a performance study, reported device performance, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.
Therefore, I cannot extract the requested information from the provided text. This document is a regulatory approval letter, not a technical report detailing performance study results.
§ 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.