STERI-MATE STERILIZABLE HANDPIECE

STERI-MATE STERILIZABLE HANDPIECE is an FDA 510(k)-cleared medical device (K023697) manufactured by Dentsply International. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 5, 2002. Regulation: 8.