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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gutta-Percha
510(k) Number K896663
Device Name ENDO-PREP
Applicant
Pulpdent Corp.
80 Oakland St.
P.O. Box 780
Watertown,  MA  02471 -0780
Applicant Contact KENNETH J BERK
Correspondent
Pulpdent Corp.
80 Oakland St.
P.O. Box 780
Watertown,  MA  02471 -0780
Correspondent Contact KENNETH J BERK
Regulation Number872.3850
Classification Product Code
EKM  
Date Received11/24/1989
Decision Date 02/14/1990
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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