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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 K112946
Device Name ACTIV VARNISH
Applicant
PULPDENT CORPORATION
80 OAKLAND ST.
P.O. BOX 780
WATERTOWN,  MA  02471 -0780
Applicant Contact KENNETH J BERK
Correspondent
PULPDENT CORPORATION
80 OAKLAND ST.
P.O. BOX 780
WATERTOWN,  MA  02471 -0780
Correspondent Contact KENNETH J BERK
Regulation Number872.3260
Classification Product Code
LBH  
Date Received10/04/2011
Decision Date 12/09/2011
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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