
Coltene/Whaledent AG
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TEMPOSIL, MODEL 6720 is an FDA 510(k)-cleared medical device (K050426) manufactured by Coltene/Whaledent AG. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 2005. Regulation: 8.