
Coe Laboratories, Inc.
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SELF-CURING HARD DENTURE LINER is an FDA 510(k)-cleared medical device (K820673) 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 8, 1982. Regulation: 8.