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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 K122569
Device Name LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR
Original Applicant
3M COMPANY
2510 conway avenue
st. paul,  MN  55144
Original Contact ginger cantor
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/23/2012
Decision Date 09/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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