DEVICE: Mondial 6, D2 / L331, CE (J014660172260)
Device Identifier (DI) Information
Mondial 6, D2 / L331, CE
66017226
In Commercial Distribution
66017226
Heraeus Kulzer GmbH
66017226
In Commercial Distribution
66017226
Heraeus Kulzer GmbH
Denture, plastic, teeth
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
38643 | Resin artificial teeth |
Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELM | Denture, plastic, teeth |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K060994 | 000 |
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
af878b57-2ef2-4e5c-b47a-bb8dcfd917d2
July 06, 2018
3
September 15, 2016
July 06, 2018
3
September 15, 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 |
---|---|---|---|---|---|
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
[?]
+1(800)431-1785
xxx@xxx.xxx
xxx@xxx.xxx