
Shofu Dental Corp.
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SUMMAR NON-PRECIOUS, CERAMIC ALLOY is an FDA 510(k)-cleared medical device (K811013) manufactured by Shofu Dental Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 1981. Regulation: 8.