DEVICE: FINGER SPREADER Pointed (J003A0206021900001)

Device Identifier (DI) Information

FINGER SPREADER Pointed
A020602190000
Not in Commercial Distribution
A020602190000
MAILLEFER INSTRUMENTS HOLDING Sàrl
J003A0206021900001
HIBCC
June 30, 2023
1
480538495 *Terms of Use
N/A
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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
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FDA Product Code

[?]
Product Code Product Code Name
EKK SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: N/A
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

de20710c-5816-47d7-a098-3df4cd5fa3d5
June 06, 2025
2
September 30, 2022
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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