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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K872147
Device Name KERR CAVALITE
Applicant
Kerr Corporation (Danbury)
One Thomas Cir.
Washington,  DC  20005
Applicant Contact KURZMAN, PC
Correspondent
Kerr Corporation (Danbury)
One Thomas Cir.
Washington,  DC  20005
Correspondent Contact KURZMAN, PC
Regulation Number872.3250
Classification Product Code
EJK  
Date Received06/04/1987
Decision Date 08/26/1987
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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