
Synthes (Usa)
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SYNTHES (USA) CHRONOS-BETA-TCP is an FDA 510(k)-cleared medical device (K053022) manufactured by Synthes (Usa). 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 22, 2006. Regulation: 8.