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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 K120453
Device Name FILTEK BULK FILL FLOWABLE RESTORATIVE
Applicant
3M Espe Dental Products
3m Center; Bldg. 260-2a-11
St. Paul,  MN  55144
Applicant Contact SCOTT ERICKSON
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/14/2012
Decision Date 03/19/2012
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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