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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
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