(85 days)
Aadva Zr Coloring Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.
Aadva Zr Coloring Liquid is a liquid used for the complete or partial coloration of milled substructures before sintering. Aadva Zr Coloring Liquid is available in 8 shades.
The provided text is a 510(k) summary for a dental device (Aadva Zr Coloring Liquid) and its FDA clearance letter. It does not contain information about acceptance criteria, device performance metrics, or any studies involving human readers, training sets, or ground truth establishment.
This document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed performance study as would be seen for AI/ML-based medical devices.
Therefore, I cannot provide the requested information from this document.
§ 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.