IMPREGUM PENTA

Material, Impression

ESPE DENTAL AG

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

Pre-market Notification Details

Device IDK992897
510k NumberK992897
Device Name:IMPREGUM PENTA
ClassificationMaterial, Impression
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 CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-27
Decision Date1999-09-08
Summary:summary

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