
Bonart Co., Ltd.
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BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES is an FDA 510(k)-cleared medical device (K080761) 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 24, 2008. Regulation: 8.