KETAC-MOLAR QUICK

Material, Tooth Shade, Resin

ESPE DENTAL AG

The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Ketac-molar Quick.

Pre-market Notification Details

Device IDK994251
510k NumberK994251
Device Name:KETAC-MOLAR QUICK
ClassificationMaterial, Tooth Shade, Resin
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 CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-17
Decision Date2000-01-03
Summary:summary

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