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 IDD9821712501
NIH Device Record Keyf6f36b74-0fed-4c0d-b100-dbfa81370652
Commercial Distribution StatusIn Commercial Distribution
Brand NameLuxaPrint Ortho Flex 385
Version Model Number171250
Catalog Number171250
Company DUNS342962296
Company NameDMG Digital Enterprises SE
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
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD9821712500 [Primary]
HIBCCD9821712501 [Package]
Contains: D9821712500
Package: [1 Units]
In Commercial Distribution

FDA Product Code

QJJIndirect Bonding Tray

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-09
Device Publish Date2022-09-01

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D9821712501(Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer tra

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