ADHESIVE EXL-759

Agent, Tooth Bonding, Resin

3M ESPE AG

The following data is part of a premarket notification filed by 3m Espe Ag with the FDA for Adhesive Exl-759.

Pre-market Notification Details

Device IDK110302
510k NumberK110302
Device Name:ADHESIVE EXL-759
ClassificationAgent, Tooth Bonding, Resin
Applicant 3M ESPE AG ESPE PLATZ Seefeld, Bavaria,  DE D-82229
ContactDesi W Soegiarto
CorrespondentDesi W Soegiarto
3M ESPE AG ESPE PLATZ Seefeld, Bavaria,  DE D-82229
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-02
Decision Date2011-05-19
Summary:summary

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