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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 K110131
Device Name LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
Applicant
3M Espe Dental Products
3m Center, Bldg. 260-2a-11
St. Paul,  MN  55144
Applicant Contact GINGER CANTOR
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact GINGER CANTOR
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
EBG  
Date Received01/18/2011
Decision Date 01/21/2011
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
Recalls CDRH Recalls
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