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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 K930989
Device Name PULPDENT UNFILLED DUAL CURE BONDING RESIN
Applicant
Pulpdent Corp.
80 Oakland St.
P.O. Box 780
Watertown,  MA  02471
Applicant Contact KENNETH J BERK
Correspondent
Pulpdent Corp.
80 Oakland St.
P.O. Box 780
Watertown,  MA  02471
Correspondent Contact KENNETH J BERK
Regulation Number872.3200
Classification Product Code
KLE  
Date Received02/25/1993
Decision Date 04/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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