(73 days)
Conventional crown and bridge, inlays, onlays, milling work, cast partial denture-frames.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, the results of a study, or any details related to device performance in the context of a clinical or analytical study. The document is an FDA 510(k) clearance letter for a dental device named "Yellow Special," indicating that it has been found substantially equivalent to a predicate device. It lists the device name, regulation number, product code, and indications for use, but no performance data, study design, or acceptance criteria are discussed.
§ 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.