(58 days)
It is palladium free, rich gold colored, Type-IV extra hard alloy for Hard Inlays, Crowns, Fixed Bridgework. This High noble alloy offers strength, resilency and hardness for hard inlays and longspan bridges. It resists tarnish and discoloration and can be quenched (Soft ) and heat-treated ( Hardened ).It can be used for restorative works.
Benchmark- IV is a palladium free, rich gold colored, Type-IV extra hard alloy.
This document is a 510(k) clearance letter from the FDA for a dental alloy named "Benchmark-IV." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/medical device study.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies based on the provided 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.