Home GUDID EDMG1712100
LuxaPrint Ortho Plus 385
Primary DI EDMG1712100
Brand LuxaPrint Ortho Plus 385
Company DMG Chemisch-Pharmazeutische Fabrik GmbH
Model 171210
Catalog number 171210
Device description (Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 500 g
Published 2019-06-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name DYT Maintainer, Space Preformed, Orthodontic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYT Maintainer, Space Preformed, Orthodontic Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EDMG1712101 Package HIBCC 1 Not in Commercial Distribution EDMG1712100 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental appliance fabrication material, resin A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 15 Degrees Celsius 25 Degrees Celsius Handling Environment Temperature 59 Degrees Fahrenheit 77 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Store in a location that is protected against light. Always keep the container tightly sealed.
Regulatory Flags# DUNS number 320744915 Device count 1 Premarket exempt true Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published EDMG1103600 Luxatemp® Automix Solar 110360 110360 2016-09-21 EDMG1103680 Luxatemp® Automix Plus 110368 110368 2016-09-21 EDMG1104000 Luxatemp® Automix Plus 110400 110400 2016-09-21 EDMG1104010 Luxatemp® Automix Plus 110401 110401 2016-09-21 EDMG1104020 Luxatemp® Automix Plus 110402 110402 2016-09-21 EDMG1104030 Luxatemp® Automix Plus 110403 110403 2016-09-21 EDMG1104040 Luxatemp® Automix Plus 110404 110404 2016-09-21 EDMG1104060 Luxatemp® Automix Plus 110406 110406 2016-09-21 EDMG1105850 Luxatemp® Fluorescence 110585 110585 2016-09-21 EDMG1105860 Luxatemp® Fluorescence 110586 110586 2016-09-21 EDMG1105870 Luxatemp® Fluorescence 110587 110587 2016-09-21 EDMG1105880 Luxatemp® Fluorescence 110588 110588 2016-09-21 EDMG1105890 Luxatemp® Fluorescence 110589 110589 2016-09-21 EDMG1107100 Luxatemp® Fluorescence 110710 110710 2016-09-21 EDMG1107190 Luxatemp® Fluorescence 110719 110719 2016-09-23 EDMG1107220 Luxatemp® Fluorescence 110722 110722 2016-09-23 EDMG1107230 Luxatemp® Fluorescence 110723 110723 2016-09-23 EDMG2123841 LuxaBond - Total Etch 212384 212384 2016-09-23 EDMG2133201 TECO 213320 213320 2016-09-22 EDMG2130801 Vitique 213080 213080 2016-09-22
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