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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K882576
Device Name ACID ETCH GEL
Applicant
Pulpdent Corp. of America
75 Boylston St.
P.O. Box 689
Brookline,  MA  02147
Applicant Contact KENNETH BERK
Correspondent
Pulpdent Corp. of America
75 Boylston St.
P.O. Box 689
Brookline,  MA  02147
Correspondent Contact KENNETH BERK
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/22/1988
Decision Date 07/15/1988
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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