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Kaltenbach & Voigt GmbH & Co.
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COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE is an FDA 510(k)-cleared medical device (K080677) manufactured by Kaltenbach & Voigt GmbH & Co.. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 5, 2008. Regulation: 8.