3M ESPE HAUR

Material, Tooth Shade, Resin

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Espe Haur.

Pre-market Notification Details

Device IDK010781
510k NumberK010781
Device Name:3M ESPE HAUR
ClassificationMaterial, Tooth Shade, Resin
Applicant 3M COMPANY 3M CENTER, BLDG. 260-2B-12 St Paul,  MN  55144
ContactScott Erickson
CorrespondentScott Erickson
3M COMPANY 3M CENTER, BLDG. 260-2B-12 St Paul,  MN  55144
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-15
Decision Date2001-04-13

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