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Coltene/Whaledent AG
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JET BLUE BITE is an FDA 510(k)-cleared medical device (K051243) 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 June 22, 2005. Regulation: 8.