(48 days)
BK BLANK is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges.
Not Found
The provided text describes a 510(k) premarket notification for a dental device called "BK Blank 20, 40, 65, 90." This document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to legally marketed predicate devices for its intended use as a substructure for porcelain-fused ceramic fixed dental restorations (crowns and bridges).
However, the provided text does not contain any information about:
- Acceptance criteria or reported device performance
- Details of any study conducted to meet acceptance criteria
- Sample sizes for test or training sets
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- Multi-reader multi-case (MRMC) studies
- Standalone algorithm performance
- Type of ground truth used
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about the study, as this information is not present in the given text.
§ 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.