FLASH PENTA MB QUICK, FLASH MB QUICK

Material, Impression

3M ESPE AG

The following data is part of a premarket notification filed by 3m Espe Ag with the FDA for Flash Penta Mb Quick, Flash Mb Quick.

Pre-market Notification Details

Device IDK140602
510k NumberK140602
Device Name:FLASH PENTA MB QUICK, FLASH MB QUICK
ClassificationMaterial, Impression
Applicant 3M ESPE AG ESPE PLATZ Seefeld,  DE D-82229
ContactRuediger Franke
CorrespondentRuediger Franke
3M ESPE AG ESPE PLATZ Seefeld,  DE D-82229
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-10
Decision Date2014-06-05
Summary:summary

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