BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER

BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER is an FDA 510(k)-cleared medical device (K130137) manufactured by Coltene/Whaledent. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 2013. Regulation: 8.