PREMIER ULTRASONIC SCALER AND INSERTS

PREMIER ULTRASONIC SCALER AND INSERTS is an FDA 510(k)-cleared medical device (K010195) manufactured by Premier Dental Products Co.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 16, 2001. Regulation: 8.