(58 days)
Low fusing ceramic crowns, small bridges, inlays, onlays
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The provided text is a 510(k) clearance letter from the FDA for a dental alloy named "Aurofluid Plus". 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 studies, sample sizes, expert qualifications, adjudication methods, or MRMC/standalone studies traditionally associated with AI/ML medical devices.
The information requested in your prompt (e.g., acceptance criteria, study details, expert consensus, training sets) is typically found in a device's 510(k) summary, clinical study reports, or performance testing documentation, not in the FDA clearance letter itself.
Therefore, I cannot fulfill your request with the input provided. The document is a regulatory approval, not a technical performance 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.