BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO

BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO is an FDA 510(k)-cleared medical device (K081550) manufactured by Bonart Co., 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 August 27, 2008. Regulation: 8.