DIAMONDCOAT ULTRASONIC INSERTS

DIAMONDCOAT ULTRASONIC INSERTS is an FDA 510(k)-cleared medical device (K030111) 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 February 6, 2003. Regulation: 8.