(54 days)
Fabrication of Dental Crowns, Bridges, Inlays and Low-fusing Porcelain-fused-to-metal Applications.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental device named "Pagalinor 4". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets specific criteria.
The letter focuses on regulatory approval based on "substantial equivalence" rather than specific performance data from a clinical or technical study designed to evaluate and report against detailed acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The document is a regulatory approval notice, not a study report.
§ 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.