LuxaPrint Ortho 385 171207

GUDID EMDG1712071

(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 @ 1000 g

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental appliance fabrication material, cured
Primary Device IDEMDG1712071
NIH Device Record Key035e3e98-6c6e-4028-aa67-1301b59e9f54
Commercial Distribution StatusIn Commercial Distribution
Brand NameLuxaPrint Ortho 385
Version Model Number171207
Catalog Number171207
Company DUNS320744915
Company NameDMG Chemisch-Pharmazeutische Fabrik GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a location that is protected against light. Always keep the container tightly sealed.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEMDG1712070 [Primary]
HIBCCEMDG1712071 [Package]
Contains: EMDG1712070
Package: [1 Units]
In Commercial Distribution

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-02
Device Publish Date2019-06-24

On-Brand Devices [LuxaPrint Ortho 385]

EMDG1712071(Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/
EDMG1712061(Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/
EDMG1712560(Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/

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