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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 K092141
Device Name VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH
Applicant
3M Espe Dental Products
3m Center, Bldg. 275-2w-08
St. Paul,  MN  55144
Applicant Contact TAMARA L STANCZAK
Correspondent
3M Espe Dental Products
3m Center, Bldg. 275-2w-08
St. Paul,  MN  55144
Correspondent Contact TAMARA L STANCZAK
Regulation Number872.3260
Classification Product Code
LBH  
Date Received07/15/2009
Decision Date 03/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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