
Sirona Dental Systems GmbH
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PERIOSCAN ULTRASONIC SCALER is an FDA 510(k)-cleared medical device (K050354) manufactured by Sirona Dental Systems GmbH. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 20, 2005. Regulation: 8.