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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
Applicant
SYLPHAR N.V.
PIAZZA ALBANIA 10
ROME, ITALY,  IT 00153
Applicant Contact ROGER GRAY
Correspondent
SYLPHAR N.V.
PIAZZA ALBANIA 10
ROME, ITALY,  IT 00153
Correspondent Contact ROGER GRAY
Regulation Number872.3260
Classification Product Code
LBH  
Date Received09/04/2012
Decision Date 01/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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