DEVICE: TempoCem® Automix (EDMG1103000)
Device Identifier (DI) Information
TempoCem® Automix
110300
In Commercial Distribution
110300
DMG Chemisch-Pharmazeutische Fabrik GmbH
110300
In Commercial Distribution
110300
DMG Chemisch-Pharmazeutische Fabrik GmbH
Temporary cement automix system. The temporary cement that keeps its promise. Content: 1 cartridge @ 25 ml paste, accessories.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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Yes | |
No | |
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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? |
---|---|---|---|---|
62200 | Zinc oxide eugenol dental cement |
A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EMB | Zinc Oxide Eugenol |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K110759 | 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
e268ab1c-cad1-4140-8863-b1b42f4875b6
November 17, 2020
1
November 09, 2020
November 17, 2020
1
November 09, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
EDMG1103001 | 1 | EDMG1103000 | In Commercial Distribution | ||
EDMG1103008 | 12 | EDMG1103001 | 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