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Septodont S.A.S.
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ACROSEAL ROOT CANAL OR APICAL SEALER is an FDA 510(k)-cleared medical device (K023976) manufactured by Septodont S.A.S.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 2003. Regulation: 8.