
Coe Laboratories, Inc.
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TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING is an FDA 510(k)-cleared medical device (K885010) manufactured by Coe Laboratories, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 1989. Regulation: 8.