DEVICE: Honigum Pro Heavy Quad Fast (EDMG9898380)
Device Identifier (DI) Information
Honigum Pro Heavy Quad Fast
989838
In Commercial Distribution
989838
DMG Chemisch-Pharmazeutische Fabrik GmbH
989838
In Commercial Distribution
989838
DMG Chemisch-Pharmazeutische Fabrik GmbH
Impression material, heavy-bodied consistency. Impressions made your way. Content: 4 cartridges @ 50 ml paste, Accessories
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? |
---|---|---|---|---|
35866 | Silicone dental impression material |
An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELW | Material, Impression |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K000878 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: 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
fbedc40a-4dfe-4a88-b9fd-7f0cade486da
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 |
---|---|---|---|---|---|
EDMG9898388 | 6 | EDMG9898381 | In Commercial Distribution | ||
EDMG9898381 | 4 | EDMG9898380 | 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