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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 K103461
Device Name COLGATE DESENSITIZING DENTAL CREAM
Applicant
COLGATE-PALMOLIVE CO.
909 RIVER RD.
PISCATAWAY,  NJ  08855 -1343
Applicant Contact CHARLES P IRELAND
Correspondent
COLGATE-PALMOLIVE CO.
909 RIVER RD.
PISCATAWAY,  NJ  08855 -1343
Correspondent Contact CHARLES P IRELAND
Regulation Number872.3260
Classification Product Code
LBH  
Date Received11/24/2010
Decision Date 09/13/2011
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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