LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2

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 Luxacrown, Shade A1, A2, A3, A3.5; Luxacrown B1, B3, C2, D2.

Pre-market Notification Details

Device IDK183337
510k NumberK183337
Device Name:LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2
ClassificationCrown And Bridge, Temporary, Resin
Applicant DMG Chemisch-Pharmazeutische Fabrik GmbH Elbgaustrasse 248 Hamburg,  DE 22547
ContactSonja Toeppen
CorrespondentPamela Papineau
Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer,  MA  01432
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-03
Decision Date2019-05-29

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