(56 days)
Fabrication of Dental Crowns, Bridges, Inlays and Cast Partial-denture Frames.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a dental material called "Aurofluid M." This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to existing devices, not on performance studies or acceptance criteria for a new device's performance.
§ 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.