DEVICE: CONDYLOFORM II NFCplus (E1996602181)
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| Yes | |
| 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 [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c7749e39-45ac-49d9-9a92-6db86d924703
June 03, 2020
3
October 05, 2016
June 03, 2020
3
October 05, 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 |
|---|---|
| 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
[?]
No Customer Contact currently defined