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FDA 510(k) K153549, OSSIX VOLUMAX, by Datum Dental, Ltd.

FDA 510(k) K153549, OSSIX VOLUMAX, by Datum Dental, Ltd.

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510(K) Number: K153549
Device Name: OSSIX VOLUMAX
Manufacturer: Datum Dental, Ltd.
Device Classification Name: barrier, animal source, intraoral
Regulation Number: 872.3930
Classification Product Code: NPL
Date Received: 12/11/2015
Decision Date: 08/04/2016
Regulation Medical Specialty: Dental
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