LuxaPrint Ortho Flex 385 171250

GUDID D9821712501

(Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer trays (in case of indirect bonding of brackets) using 3D printing. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Shade: Transparent, Content: 1 Bottle @ 500 g

DMG Digital Enterprises SE

Dental appliance fabrication material, resin

• Primary Device ID: D9821712501
• NIH Device Record Key: f6f36b74-0fed-4c0d-b100-dbfa81370652
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LuxaPrint Ortho Flex 385
• Version Model Number: 171250
• Catalog Number: 171250
• Company DUNS: 342962296
• Company Name: DMG Digital Enterprises SE
• 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: 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

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D9821712500 [Primary]
HIBCC	D9821712501 [Package]; Contains: D9821712500; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• QJJ: Indirect Bonding Tray

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: 2022-09-09
• Device Publish Date: 2022-09-01

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• D9821712751: (Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer tra
• D9821712731: (Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer tra
• D9821712531: (Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer tra
• D9821712521: (Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer tra
• D9821712511: (Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer tra
• D9821712501: (Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer tra