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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 K221695
Device Name 3M Filtek Supreme Flowable Restorative
Applicant
3M Company Espe Dental Products
2510 Conway Ave.
Saint Paul,  MN  55144
Applicant Contact Regina Feferman-Savvateev
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
EBC  
Date Received06/10/2022
Decision Date 06/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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