DEVICE: LuxaPost (EDMG1107351)

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Device Record History
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Device Identifier (DI) Information
LuxaPost
110735
In Commercial Distribution
110735
DMG Chemisch-Pharmazeutische Fabrik GmbH
EDMG1107351
HIBCC

1
320744915 *Terms of Use
Drill for LuxaPost Ø 1.375 mm. Content: 1 drill (Ø 1.375)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
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?
35784 Endodontic broach, serrated, reusable
A hand-held, manual, dental, cutting instrument with a slender, tapered, serrated/barbed tip intended to be used for shaping and enlarging holes in root canal tissue, particularly dentine, or for extirpating pulp. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EJL Bur, Dental
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Liquid Chemical
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 1.375 Millimeter
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Device Record Status
de45433d-38a9-4a44-a47a-847a9640df33
September 09, 2022
1
September 01, 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

[?]
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
Yes
Yes
No
No CLOSE

Customer Contact

[?]
201-894-5505
ccosta@dmg-america.com
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