(21 days)
Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers and crowns.
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for Vitablocs®, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as registration, labeling, and good manufacturing practices, and specifies the indications for use.
However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or ground truth for any studies.
- Information about experts, adjudication methods, or MRMC comparative effectiveness studies.
- Information about standalone algorithm performance or training sets.
Therefore, I cannot fulfill your request based on the given input.
§ 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.