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Heraeus Kulzer, Inc., Dental Products Division
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FLEXITIME BITE is an FDA 510(k)-cleared medical device (K082591) manufactured by Heraeus Kulzer, Inc., Dental Products Division. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2008. Regulation: 8.