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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K894219
Device Name TEMP BOND NE
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 Number872.3275
Classification Product Code
EMA  
Date Received06/19/1989
Decision Date 09/18/1989
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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