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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K102163
Device Name REALSEAL XT SEALER
Applicant
Kerr Corporation
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact WENDY GARMEN
Correspondent
Kerr Corporation
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact WENDY GARMEN
Regulation Number872.3820
Classification Product Code
KIF  
Date Received08/02/2010
Decision Date 10/16/2010
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
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