NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN


Device Classification Name

agent, polishing, abrasive, oral cavity

510(k) Number K121698
Device Name NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
Applicant
DENTSPLY INTERNATIONAL INC.
221 west philadelphia st.
suite 60
york, 
PA 
17404

Applicant Contact helen lewis
Correspondent
DENTSPLY INTERNATIONAL INC.
221 west philadelphia st.
suite 60
york, 
PA 
17404

Correspodent Contact helen lewis
Regulation Number 872.6030
Classification Product Code
EJR  
Date Received 06/08/2012
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