
Den-Mat Corp.
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DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) is an FDA 510(k)-cleared medical device (K860971) manufactured by Den-Mat 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 March 24, 1986. Regulation: 8.