(69 days)
GC Aadva Zr Disks are used to fabricate crown and bridge frameworks, both anterior and posterior.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a dental device called "GC Aadva Zr Disk." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment typically associated with AI/ML device evaluations.
The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the trade/device name, regulation number, regulation name, regulatory class, and product code. It also includes an "Indications for Use" statement.
Therefore, I cannot provide the requested information based on the input text. The questions posed are relevant to the evaluation of AI/ML-driven medical devices, but this document pertains to a traditional dental material (porcelain powder for clinical use).
§ 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.