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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cleanser, root canal
510(k) Number K962743
Device Name PULPDENT SODIUM HYPOCHLORITE SOLUTION
Applicant
PULPDENT CORP.
80 OAKLAND ST.
WATERTOWN,  MA  02472
Applicant Contact KENNETH J BERK
Correspondent
PULPDENT CORP.
80 OAKLAND ST.
WATERTOWN,  MA  02472
Correspondent Contact KENNETH J BERK
Classification Product Code
KJJ  
Date Received07/15/1996
Decision Date 08/06/1996
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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