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NON-PRECIOUS METAL ALLOY FOR VENEERS, CROWNS, BRIDGES, INLAYS, ONLAYS.

Sowell Nickel-Chrome Non-Precious Metal Alloy

This document is a 510(k) clearance letter from the FDA for a dental alloy, not a study report or clinical trial. Therefore, it does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

This means the device (Sowell Nickel-Chrome Non-Precious Metal Alloy) was cleared based on its substantial equivalence to a legally marketed predicate device, not on a new study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document.

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