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Italia Medica S.R.L.
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PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE is an FDA 510(k)-cleared medical device (K080220) manufactured by Italia Medica S.R.L.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 2008. Regulation: 8.