(136 days)
The Zirkondent is indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses.
Not Found
The provided document is a 510(k) clearance letter for a dental device called "Zirkondent," which is a porcelain powder for clinical use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI assistance.
The letter confirms that the FDA has reviewed the device's premarket notification and determined it to be substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory compliance and the permission to market the device, rather than detailed performance study results.
Therefore, I cannot fulfill your request for the information outlined in your prompt based on the provided 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.