DEVICE: LuxaPrint Ortho Flex 385 (D9821712810)
Device Identifier (DI) Information
LuxaPrint Ortho Flex 385
171281
In Commercial Distribution
171281
DMG Digital Enterprises SE
171281
In Commercial Distribution
171281
DMG Digital Enterprises SE
(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 @ 2 kg
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
16730 | Dental appliance fabrication material, resin |
A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QJJ | Indirect Bonding Tray |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 25 Degrees Celsius |
Special Storage Condition, Specify: 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 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e6bb587f-d607-4961-a82c-da7139452e42
July 08, 2022
1
June 30, 2022
July 08, 2022
1
June 30, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D9821712811 | 1 | D9821712810 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
201-894-5505
ccosta@dmg-america.com
ccosta@dmg-america.com