(114 days)
Vintage ZR is high fusing porcelain used for fabricating ZrO2 framework bonded all ceramic restorations.
Vintage ZR is high fusing porcelain used for fabricating ZrO2 framework bonded all ceramic restorations.
The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for a dental device called "Vintage ZR." These documents do not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the full 510(k) submission, which is not provided here.
Therefore, I cannot answer your request based on the provided input. The documents confirm that "Vintage ZR" is a high fusing porcelain for fabricating ZrO2 framework bonded all-ceramic restorations and that it has received 510(k) clearance (K052033) from the FDA.
§ 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.