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Satelec - Acteon Group
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PROULTRA PIEZO ULTRASONIC is an FDA 510(k)-cleared medical device (K113430) manufactured by Satelec - Acteon Group. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2012. Regulation: 8.