SCALETRON PIEZO ULTRASOUND SCALER

SCALETRON PIEZO ULTRASOUND SCALER is an FDA 510(k)-cleared medical device (K033120) manufactured by Pac-Dent International (Suzhou), Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 28, 2004. Regulation: 8.