ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL

Material, Tooth Shade, Resin

DENTSPLY INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Adaptable Composite Resin Restorative Material.

Pre-market Notification Details

Device IDK083841
510k NumberK083841
Device Name:ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL
ClassificationMaterial, Tooth Shade, Resin
Applicant DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. SUITE 60 York,  PA  17404
ContactHelen Lewis
CorrespondentHelen Lewis
DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. SUITE 60 York,  PA  17404
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-24
Decision Date2009-04-14
Summary:summary

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