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Sybron Dental Specialties, Inc.
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SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS is an FDA 510(k)-cleared medical device (K080089) manufactured by Sybron Dental Specialties, 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 September 3, 2008. Regulation: 8.