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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 K843025
Device Name COMMAND ENAMEL-DENT DENTAL ADHESIVE
Applicant
Kerr Corporation (Danbury)
Suite 1200
Washington,  DC  20005
Applicant Contact STEPHEN KURZMAN
Correspondent
Kerr Corporation (Danbury)
Suite 1200
Washington,  DC  20005
Correspondent Contact STEPHEN KURZMAN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/01/1984
Decision Date 10/25/1984
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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