ELIPAR FREELIGHT

Activator, Ultraviolet, For Polymerization

ESPE DENTAL AG

The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Elipar Freelight.

Pre-market Notification Details

Device IDK011154
510k NumberK011154
Device Name:ELIPAR FREELIGHT
ClassificationActivator, Ultraviolet, For Polymerization
Applicant ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria,  DE D-82229
ContactAndreas Petermann
CorrespondentAndreas Petermann
ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria,  DE D-82229
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-16
Decision Date2001-05-16

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