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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 K083610
Device Name FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
Applicant
3M Company
3m Center
Bldg. 275-2w-08
St Paul,  MN  55144 -1000
Applicant Contact SCOTT ERICKSON
Correspondent
3M Company
3m Center
Bldg. 275-2w-08
St Paul,  MN  55144 -1000
Correspondent Contact SCOTT ERICKSON
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/08/2008
Decision Date 12/17/2008
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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