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Addent, Inc.
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MICROLUX/DL MICROLUX/BLU BIO/SCREEN is an FDA 510(k)-cleared medical device (K121282) manufactured by Addent, 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 July 23, 2012. Regulation: 8.