DENTALIS KEZ ENDODONITC SEALER

DENTALIS KEZ ENDODONITC SEALER is an FDA 510(k)-cleared medical device (K971642) manufactured by Neodental Chemical Products Co., Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 23, 1997. Regulation: 8.