DEVICE: LuxaCore® Automix Dual (EDMG2120110)
Device Identifier (DI) Information
LuxaCore® Automix Dual
212011
In Commercial Distribution
212011
DMG Chemisch-Pharmazeutische Fabrik GmbH
212011
In Commercial Distribution
212011
DMG Chemisch-Pharmazeutische Fabrik GmbH
Core build-up composite. Core buildups and post cementation with 5 stars. Content: 1 cartridge @ 50 ml paste, accessories. Color: A3.
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? |
---|---|---|---|---|
35870 | Dental composite resin |
A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBF | Material, Tooth Shade, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K012307 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: If possible, store unopened material in a refrigerator. |
Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
bbb9c257-06e6-49f8-8ce9-950d43192d80
July 06, 2018
3
September 22, 2016
July 06, 2018
3
September 22, 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 |
---|---|---|---|---|---|
EDMG2120118 | 12 | EDMG2120111 | In Commercial Distribution | ||
EDMG2120111 | 1 | EDMG2120110 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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