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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K853447
Device Name POLYCARB WATER SET
Applicant
Pulpdent Corp. of America
75 Boylston St.
P.O. Box 689
Brookline,  MA  02147
Applicant Contact KENNETH J BERK
Correspondent
Pulpdent Corp. of America
75 Boylston St.
P.O. Box 689
Brookline,  MA  02147
Correspondent Contact KENNETH J BERK
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/16/1985
Decision Date 10/16/1985
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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