LuxaPrint Ortho Plus 405 171213

GUDID D9821712131

(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 Digital Enterprises SE

Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin

• Primary Device ID: D9821712131
• NIH Device Record Key: 0497d7d6-9d7b-4f32-b60d-33f497228ed1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LuxaPrint Ortho Plus 405
• Version Model Number: 171213
• Catalog Number: 171213
• Company DUNS: 342962296
• Company Name: DMG Digital Enterprises SE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com
• Phone: 201-894-5505
• Email: ccosta@dmg-america.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D9821712130 [Primary]
HIBCC	D9821712131 [Package]; Contains: D9821712130; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• MQC: Mouthguard, Prescription

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: 2021-09-28
• Device Publish Date: 2021-09-20

On-Brand Devices [LuxaPrint Ortho Plus 405]

• D9821712601: (Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/
• D9821712131: (Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/
• D9821712121: (Meth) acrylate-based light-curing resin exclusively for use in the dental laboratory. For DLP/