LUXATEMP AUTOMIX

Crown And Bridge, Temporary, Resin

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH

The following data is part of a premarket notification filed by Dmg Chemisch Pharmazeutische Fabrik Gmbh with the FDA for Luxatemp Automix.

Pre-market Notification Details

Device IDK924830
510k NumberK924830
Device Name:LUXATEMP AUTOMIX
ClassificationCrown And Bridge, Temporary, Resin
Applicant DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH ELBGAUSTRABE 148 2000 HAMBURG 53 Germany,  GR
ContactGiesen)
CorrespondentGiesen)
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH ELBGAUSTRABE 148 2000 HAMBURG 53 Germany,  GR
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-25
Decision Date1994-04-29

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