DEVICE: EDENTA (E312201961)
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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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? |
|---|---|---|---|---|
| 16701 | Dental restoration retention pin kit |
A collection of various dental instruments, devices and materials intended for the insertion of permanent pins in healthy dentin to provide retention and/or stabilization of dental restorations such as fillings and crowns. It is typically presented as a kit and contains, e.g., retention pins of incrementing sizes, a selection of dental drills, and the necessary instruments to facilitate the procedure. This is a reusable device.
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Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| EBL | PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS |
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
e0211392-c877-45df-b6cd-ee5a3db04d83
February 11, 2022
1
February 03, 2022
February 11, 2022
1
February 03, 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 |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
E31220196101
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined