(64 days)
MINERVA 58 ALLOY is indicated as a dental alloy for fabricating MOD inlays, crowns, bridges, precision milling bars and attachments, and partial dentures.
MINERVA 58 ALLOY is a high noble, gold-based dental alloy.
The provided document is a 510(k) summary for a dental alloy, MINERVA 58 ALLOY, and not an AI/ML device. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition and prior marketing history in Europe.
§ 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.