(52 days)
Fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and Implant-supported Prosthesis Substructures.
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The provided document is a 510(k) clearance letter from the FDA for a dental device, "V-Supra Plus," and an "Indications for Use" statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.
Therefore, I cannot populate the table or answer the questions based on the provided text. This document is purely regulatory in nature, indicating that the device has been deemed "substantially equivalent" to predicate devices and can be marketed. It does not include the technical study results or performance metrics you are asking for.
§ 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.