(130 days)
Bettini BZD Zirconia Blocks are indicated for use in preparation of crowns, facings, inlays, and onlays to produce a hard prosthesis with a porcelain-like finish. The blocks are frequently used with porcelain overlay for translucence and related effects, and they are utilized to fabricate copings and frameworks for inlays, onlays, veneers, crowns, and anterior and posterior bridge restorations.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a dental device, "Bettini BZD Zirconia Blocks." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
This type of document primarily confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their 510(k) submission, which would typically include technical specifications, comparisons to predicate devices, and sometimes performance data, but that detailed study information is not present in this letter.
Therefore, I cannot provide the requested information based on the input document.
§ 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.