
Coe Laboratories, Inc.
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OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT is an FDA 510(k)-cleared medical device (K891140) 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 April 30, 1989. Regulation: 8.