
Pac-Dent International, Inc.
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OPTIFLOW II FLOWABLE COMPOSITE, LC is an FDA 510(k)-cleared medical device (K130672) manufactured by Pac-Dent International, 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 August 12, 2013. Regulation: 8.