DEVICE: Radix-Anker® Standard Set (J003C195DT00000001)
Device Identifier (DI) Information
Radix-Anker® Standard Set
C195DT0000000
Not in Commercial Distribution
C195DT0000000
MAILLEFER INSTRUMENTS HOLDING Sàrl
C195DT0000000
Not in Commercial Distribution
C195DT0000000
MAILLEFER INSTRUMENTS HOLDING Sàrl
Endodontic Posts Set - Dr Spang
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
45650 | Root canal post kit |
A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELR | POST, ROOT CANAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: N/A |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0fdbef63-0578-46ff-ae63-12f73a7ecde7
June 06, 2025
2
September 30, 2022
June 06, 2025
2
September 30, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined