
Sirona Dental Systems GmbH
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SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES is an FDA 510(k)-cleared medical device (K032543) manufactured by Sirona Dental Systems GmbH. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 13, 2003. Regulation: 8.