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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 K880251
Device Name KERR XR IONOMER
Applicant
KERR CORPORATION (DANBURY)
ONE THOMAS CIRCLE
WASHINGTON,  DC  20005
Applicant Contact KURZMAN, PC
Correspondent
KERR CORPORATION (DANBURY)
ONE THOMAS CIRCLE
WASHINGTON,  DC  20005
Correspondent Contact KURZMAN, PC
Regulation Number872.3275
Classification Product Code
EMA  
Date Received01/20/1988
Decision Date 06/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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