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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 K141081
FOIA Releasable 510(k) K141081
Device Name FILTEK BULK FILL POSTERIOR RESTROATIVE
Applicant
3M ESPE DENTAL PRODUCTS
2510 CONWAY AVENUE
SAINT PAUL,  MN  55144 -0000
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 Received04/25/2014
Decision Date 05/08/2014
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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