ADPER PROMPT, ADPER PROMPT L-POP

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 Adper Prompt, Adper Prompt L-pop.

Pre-market Notification Details

Device IDK060684
510k NumberK060684
Device Name:ADPER PROMPT, ADPER PROMPT L-POP
ClassificationAgent, Tooth Bonding, Resin
Applicant 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria,  DE D-82229
ContactSabine Krischer
CorrespondentSabine Krischer
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 Received2006-03-15
Decision Date2006-04-24
Summary:summary

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