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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 K844662
Device Name KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI
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 Number872.3690
Classification Product Code
EBF  
Date Received11/30/1984
Decision Date 03/25/1985
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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