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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 K060472
Device Name PREMISE FLOWABLE
Applicant
KERR CORPORATION
100 BAYVIEW CIRCLE STE 6000
NEWPORT BEACH,  CA  92660
Applicant Contact COLLEEN BOSWELL
Correspondent
KERR CORPORATION
100 BAYVIEW CIRCLE STE 6000
NEWPORT BEACH,  CA  92660
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/23/2006
Decision Date 04/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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