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Bonart Co., Ltd.
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BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) is an FDA 510(k)-cleared medical device (K071981) 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 October 25, 2007. Regulation: 8.