(83 days)
NON-FRECIOUS METAL ALLOY, CAST CROWN, BRIDGE, INLAYS, ONLAYS AND RESTORATION.
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I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a "Sowell Nickel-Chrome-Molybdenum Alloy," confirming its substantial equivalence to previously marketed devices. It details the administrative aspects of the clearance and the product's intended use (dental restorations).
There is no mention of acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies, which are typically found in a device's performance study report or marketing submission appendix, not in the clearance letter itself.
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.