(71 days)
Used in the manufacture of dental prosthetics: crowns, bridges, inlays, and onlays.
Xceram® is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
The provided text does not contain information about studies proving that the "Xceram®" device meets specific acceptance criteria.
Instead, the document is a 510(k) summary for a dental material where the claim of substantial equivalence to predicate devices is based on:
- Comparisons of formulations
- Mechanical characteristics
- Intended uses
- Identification of porcelain powders in 21 CFR 872.6660
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and a study proving their fulfillment. The section "Performance Data" explicitly states "None required" and explains the basis for substantial equivalence without referencing a performance study or acceptance criteria in the context of device performance.
§ 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.