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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 K252890
Device Name ZenSeal Pro
Applicant
Kerr Corporation
1889 W. Mission Blvd.
Pomona,  CA  91766
Applicant Contact Maria Rao
Correspondent
Kerr Corporation
1889 W. Mission Blvd.
Pomona,  CA  91766
Correspondent Contact Maria Rao
Regulation Number872.3820
Classification Product Code
KIF  
Date Received09/11/2025
Decision Date 01/07/2026
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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