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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K911286
Device Name PULPDENT ORTHODONTIC BRACKET ADHESIVE
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 Number872.3750
Classification Product Code
DYH  
Date Received03/19/1991
Decision Date 07/05/1991
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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