
D.B.I. America Corp.
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MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER is an FDA 510(k)-cleared medical device (K051910) manufactured by D.B.I. America Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 1, 2005. Regulation: 8.