
Dentsply Intl.
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ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 is an FDA 510(k)-cleared medical device (K864996) manufactured by Dentsply Intl.. 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 18, 1987. Regulation: 8.