LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE

Material, Tooth Shade, Resin

3M ESPE DENTAL PRODUCTS

The following data is part of a premarket notification filed by 3m Espe Dental Products with the FDA for Lava Ultimate Cad/cam Restorative For Cerec / E4d, Lava Ultimate Implant Crown Restorative.

Pre-market Notification Details

Device IDK110131
510k NumberK110131
Device Name:LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
ClassificationMaterial, Tooth Shade, Resin
Applicant 3M ESPE DENTAL PRODUCTS 3M CENTER, BUILDING 260-2A-11 St. Paul,  MN  55144 -1000
ContactGinger Cantor
CorrespondentGinger Cantor
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-01-18
Decision Date2011-01-21
Summary:summary

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