(80 days)
NON-PRECIOUS METAL ALLOY FOR CROWN, BRIDGE, INLAYS, ONLAY, AND RESTORATION.
NON-PRECIOUS METAL ALLOY
The provided document is a 510(k) premarket notification letter from the FDA to a medical device distributor for a "Sowell Patented Non-Precious Metal Alloy." This type of document is a formal communication from the FDA stating that a device is substantially equivalent to a predicate device already on the market, and therefore can be marketed.
Crucially, this document does NOT contain information about acceptance criteria or a study proving that the device meets those criteria.
The 510(k) pathway for medical devices in the US primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness in the same way as a PMA (Premarket Approval) might.
Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a regulatory submission that details performance testing.
§ 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.