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Coltene/Whaledent AG
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RETRACTOFOAM is an FDA 510(k)-cleared medical device (K050013) 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 February 8, 2005. Regulation: 8.