LuxaPrint Ortho 385 171206

GUDID EDMG1712061

(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

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental appliance fabrication material, cured

• Primary Device ID: EDMG1712061
• NIH Device Record Key: cd33220f-867a-40dd-b3ec-ee255d2662ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LuxaPrint Ortho 385
• Version Model Number: 171206
• Catalog Number: 171206
• Company DUNS: 320744915
• Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG1712060 [Primary]
HIBCC	EDMG1712061 [Package]; Contains: EDMG1712060; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-02
• Device Publish Date: 2019-06-24

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/