
Coltene/Whaledent, Inc.
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ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM is an FDA 510(k)-cleared medical device (K974906) manufactured by Coltene/Whaledent, 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 March 23, 1998. Regulation: 8.