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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K884533
Device Name SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM
Applicant
Block Drug Company, Inc.
257 Cornelison Ave.
Jersey City,  NJ  07302
Applicant Contact HOWARD FEINMAN
Correspondent
Block Drug Company, Inc.
257 Cornelison Ave.
Jersey City,  NJ  07302
Correspondent Contact HOWARD FEINMAN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received10/28/1988
Decision Date 04/12/1989
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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