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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Punch, Biopsy, Surgical
510(k) Number K911285
Device Name PULPDENT POLYAMIDE DENTIN LINER
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 Number872.4565
Classification Product Code
EME  
Date Received03/19/1991
Decision Date 10/09/1991
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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