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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K963921
Device Name PULPDENT SEAL-RITE UDMA
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
Regulation Number872.3765
Classification Product Code
EBC  
Date Received09/30/1996
Decision Date 11/12/1996
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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