(76 days)
Glaze used for the repair of check lines in PFMs and dental bridges.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Denseo Fairy" (Porcelain Powder for Clinical Use). It is not a study report and therefore does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device for its indicated use as a "Glaze used for the repair of check lines in PFMs and dental bridges" (Page 2, Indication for Use).
To address your request, I would need a different type of document, such as a clinical study report, a scientific publication, or a more detailed section of a 510(k) application that describes the performance data. This FDA letter solely communicates the regulatory decision of substantial equivalence.
§ 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.