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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name varnish, cavity
510(k) Number K120176
Device Name SENZZZZZ AWAY
Original Applicant
CENTRIX, INC.
11234 el camino real
ste 200
san diego,  CA  92130
Original Contact linda k schulz
Regulation Number872.3260
Classification Product Code
LBH  
Date Received01/20/2012
Decision Date 07/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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