(54 days)
ZIECON® Zirconia Ceramic Blanks are designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks. The ceramic dental blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques & MOM for design and processing to the patient-specific anterior/posterior tooth/bridge specification provided by the dental practitioner.
ZIECON® Zirconia Ceramic Dental Blanks
This document is a marketing approval letter from the FDA for a dental device, specifically "ZIECON® Zirconia Ceramic Dental Blanks". It does not contain any information about acceptance criteria, device performance studies, or AI/software algorithms.
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§ 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.