(78 days)
Vintage Art is dental ceramic stain and is used for adjusting the shade of dental ceramic restorations or prostheses. It can reproduce natural-teeth like crown restorations and prostheses when built up on dental metal ceramic porcelain, dental porcelain, dental ceramic core material and porcelain teeth.
Vintage Art is dental ceramic stain.
I am sorry, but the context provided does not contain the information requested. The document is an FDA 510(k) clearance letter for a dental ceramic product called "Vintage Art." It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document discusses:
- Device Name: Vintage Art
- Regulation Number/Name: 872.6660 / Porcelain Powder for Clinical Use
- Regulatory Class: II
- Product Code: EIH
- Indications for Use: Dental ceramic stain for adjusting the shade of dental ceramic restorations or prostheses.
However, the provided text does not contain any information regarding acceptance criteria or the details of a study that proves the device meets such criteria. Therefore, I cannot generate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.
§ 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.