DEVICE: Automix-Dispenser Type 25 1:1 (EDMG1102531)
Device Identifier (DI) Information
Automix-Dispenser Type 25 1:1
110253
In Commercial Distribution
110253
DMG Chemisch-Pharmazeutische Fabrik GmbH
110253
In Commercial Distribution
110253
DMG Chemisch-Pharmazeutische Fabrik GmbH
Automix-Dispenser, Type 25 1:1. Suitable for: LuxaCore-Automix Dual, TempoCem NE-Automix, TempoCem-Automix, PermaCem-Automix Dual, PermaCem-Automix, Honigum-Automix Light. Content: 1 dispenser.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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60885 | Dental material cartridge-plunging applicator, two-component, manual |
A hand-held manual device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is typically a pistol-like device with a cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EID | Syringe, Restorative And Impression Material |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8b429170-8d98-43f8-8cee-82ce7fb9c869
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 |
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No Package DIs found |
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