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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K844446
Device Name BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.
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 Number872.3660
Classification Product Code
ELW  
Date Received11/16/1984
Decision Date 10/29/1985
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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