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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.

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