LuxaPrint Ortho Plus 405 171212

GUDID D9821712121

(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 Digital Enterprises SE

Dental appliance fabrication material, cured

• Primary Device ID: D9821712121
• NIH Device Record Key: 5de396e8-f28e-462a-a7b7-a525989edde5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LuxaPrint Ortho Plus 405
• Version Model Number: 171212
• Catalog Number: 171212
• 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	D9821712120 [Primary]
HIBCC	D9821712121 [Package]; Contains: D9821712120; 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/