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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 K122708
Device Name REMESENSE FOR SENSITIVE TEETH
Original Applicant
SYLPHAR N.V.
piazza albania 10
rome, italy,  IT 00153
Original Contact roger gray
Regulation Number872.3260
Classification Product Code
LBH  
Date Received09/04/2012
Decision Date 01/14/2013
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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