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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name agent, polishing, abrasive, oral cavity
510(k) Number K121698
Device Name NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
Original Applicant
DENTSPLY INTERNATIONAL INC.
221 west philadelphia st.
suite 60
york,  PA  17404
Original Contact helen lewis
Regulation Number872.6030
Classification Product Code
EJR  
Date Received06/08/2012
Decision Date 08/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Clinical Trials NCT01610167
Reviewed by Third Party No
Combination Product No
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