(60 days)
HT, HT-C, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML: used to make the crown, bridge, inlay, veneer of the all-porcelain restoration.
UT, UT-C, UT-ML and 3D-PRO: used to make the crown, maximum 3-unit bridge, inlay, veneer of the all-porcelain restoration.
Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made.
The provided document is a 510(k) Premarket Notification from the FDA for a Zirconia Block used in dental restorations. This document does not describe an AI medical device or a study proving its performance against acceptance criteria.
Therefore, I cannot extract the information required to answer your questions about acceptance criteria and a study proving a device meets them. The document pertains to a dental material, not an AI or software-based medical device.
§ 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.