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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
Predetermined Change
Control Plan Authorized		 No
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