(79 days)
For Enhancement of Porcelain Bond and Color in Porcelain-Fused-to-Metal Dental Crowns and Bridges.
Not Found
This document is a 510(k) clearance letter for a dental device, specifically "Aurofilm 2000" for "Enhancement of Porcelain Bond and Color in Porcelain Fused-to-Metal Dental Crowns and Bridges." It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The letter from the FDA to Metalor Dental USA Corporation confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It discusses regulatory classifications and general controls but does not delve into the specifics of a study proving the device meets performance acceptance criteria.
Therefore, I cannot provide the requested information based on the given document.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.