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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 K100503
Device Name PULPDENT COPAL VARNISH WITH FLUORIDE
Applicant
PULPDENT CORPORATION
80 OAKLAND ST.
WATERTOWN,  MA  02472
Applicant Contact KENNETH J BERK
Correspondent
PULPDENT CORPORATION
80 OAKLAND ST.
WATERTOWN,  MA  02472
Correspondent Contact KENNETH J BERK
Regulation Number872.3260
Classification Product Code
LBH  
Date Received02/22/2010
Decision Date 05/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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