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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 K953405
Device Name HEMA-BENZ
Applicant
Health-Dent Intl., Inc.
118 W. Lake St.
Northlake,  IL  60164
Applicant Contact AL BEVILACQUA
Correspondent
Health-Dent Intl., Inc.
118 W. Lake St.
Northlake,  IL  60164
Correspondent Contact AL BEVILACQUA
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/20/1995
Decision Date 09/27/1995
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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