DEVICE: FINGER SPREADER Pointed (J003A0206021900001)
Device Identifier (DI) Information
FINGER SPREADER Pointed
A020602190000
Not in Commercial Distribution
A020602190000
MAILLEFER INSTRUMENTS HOLDING Sàrl
A020602190000
Not in Commercial Distribution
A020602190000
MAILLEFER INSTRUMENTS HOLDING Sàrl
N/A
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
37678 | Manual endodontic filling material spreader |
A hand-held, manually-operated dental instrument specifically designed to compress filling materials in a root canal, mainly in a lateral direction. The working part is tapered, circular in cross-section and has a pointed tip. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EKK | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC |
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
de20710c-5816-47d7-a098-3df4cd5fa3d5
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 |
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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
[?]
No Customer Contact currently defined