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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 K221255
Device Name SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
Applicant
Kerr Corporation
1889 W. Mission Blvd.
Pomona,  CA  91766
Applicant Contact Haiyan Wei
Correspondent
Kerr Corporation
1889 W. Mission Blvd.
Pomona,  CA  91766
Correspondent Contact Haiyan Wei
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/02/2022
Decision Date 08/31/2022
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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