DEVICE: M-access® K-REAMER (J003A11MA031060121)

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Device Record History
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Device Identifier (DI) Information
M-access® K-REAMER
A11MA03106012
Not in Commercial Distribution
A11MA03106012
MAILLEFER INSTRUMENTS HOLDING Sàrl
J003A11MA031060121
HIBCC
June 30, 2023
1
480538495 *Terms of Use
Endodontic Instrument
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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?
31878 Manual endodontic file/rasp, reusable
A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EKP REAMER, PULP CANAL, 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
022e3dc2-8653-4cf4-81a0-1267436d5c7b
June 06, 2025
2
September 30, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

[?]
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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