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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K031915
Device Name PULPDENT ETCH-RITE ROYALE
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 Number872.3200
Classification Product Code
KLE  
Date Received06/20/2003
Decision Date 08/05/2003
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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