DEVICE: Luxatemp® Automix Plus (EDMG1104040)
Device Identifier (DI) Information
Luxatemp® Automix Plus
110404
In Commercial Distribution
110404
DMG Chemisch-Pharmazeutische Fabrik GmbH
110404
In Commercial Distribution
110404
DMG Chemisch-Pharmazeutische Fabrik GmbH
Temporary crown and bridge material automix system; bis acrylic composite. A great fit. Right away. Content: 1 cartridge @ 76 g paste, accessories. Color: B1
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
31783 | Temporary dental crown/bridge |
A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBG | Crown And Bridge, Temporary, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K013674 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Do not store in the refrigerator! Protect against exposure to direct sunlight! |
Storage Environment Temperature: between 15 and 25 Degrees Celsius |
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
4b45beb7-e09b-46fe-b588-a8573d3a65ed
October 29, 2021
4
September 21, 2016
October 29, 2021
4
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
EDMG1104048 | 12 | EDMG1104041 | In Commercial Distribution | ||
EDMG1104041 | 1 | EDMG1104040 | 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
eanagnostos@dmg-america.com
eanagnostos@dmg-america.com