UNO

Agent, Tooth Bonding, Resin

3M ESPE AG DENTAL PRODUCTS

The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Uno.

Pre-market Notification Details

Device IDK071131
510k NumberK071131
Device Name:UNO
ClassificationAgent, Tooth Bonding, Resin
Applicant 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria,  DE D-82229
ContactDesi W Soegiarto
CorrespondentDesi W Soegiarto
3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria,  DE D-82229
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-23
Decision Date2007-07-25
Summary:summary

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