BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE

BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE is an FDA 510(k)-cleared medical device (K993255) manufactured by Coltene/Whaledent, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 5, 1999. Regulation: 8.