LuxaPrint Ortho Plus

Mouthguard, Prescription

DMG Digital Enterprises SE

The following data is part of a premarket notification filed by Dmg Digital Enterprises Se with the FDA for Luxaprint Ortho Plus.

Pre-market Notification Details

Device IDK210940
510k NumberK210940
Device Name:LuxaPrint Ortho Plus
ClassificationMouthguard, Prescription
Applicant DMG Digital Enterprises SE Elbgaustrasse 248 Hamburg,  DE 22547
ContactStephan Schafer
CorrespondentPamela Papineau
Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave Ayer,  MA  01432
Product CodeMQC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-29
Decision Date2021-09-03

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