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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 K163207
Device Name Filtek One Bulk Fill Restorative
Applicant
3M Company
2510 Conway Ave.
St. Paul,  MN  55144
Applicant Contact Scott Erickson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/15/2016
Decision Date 11/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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