HERMES BOND 2

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 Hermes Bond 2.

Pre-market Notification Details

Device IDK043043
510k NumberK043043
Device Name:HERMES BOND 2
ClassificationAgent, Tooth Bonding, Resin
Applicant 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria,  DE D-82229
ContactAndreas Petermann
CorrespondentAndreas Petermann
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 Received2004-11-04
Decision Date2005-01-10
Summary:summary

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