(21 days)
DENTAL PORCELAIN DESIGNED FOR USE IN THE MANUFACTURE OF PORCELAIN FUSED TO METAL RESTORATION.
Not Found
I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a dental porcelain device (SYMBIOceram / EXCELSTONE PORCELAIN).
This type of document primarily indicates that the FDA has found the device to be "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics as a device already on the market, or if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness.
The letter itself does not contain:
- Details about specific acceptance criteria for performance.
- Data from a study proving the device meets acceptance criteria.
- Information on sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
These details would typically be found in the 510(k) submission itself (which is often extensive and not publicly released in full in a simple letter like this) or in published scientific literature related to the device. The provided document is just the FDA's regulatory outcome letter.
§ 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.