DEVICE: EndoPilot retainer for apexcable (04260482990817)

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Device Record History
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Device Identifier (DI) Information
EndoPilot retainer for apexcable
EDP2
In Commercial Distribution
110 2303
Schlumbohm GmbH & Co. KG
04260482990817
GS1

1
343831731 *Terms of Use
EndoPilot retainer for apexcable
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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?
38347 Dental power tool system handpiece, line-powered
A hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
EKX Handpiece, Direct Drive, Ac-Powered
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K202906 000
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Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

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Size Type Text
No Device Sizes
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Device Record Status
ecf77da9-1658-4bf7-a31f-c4342f0d56d0
June 10, 2021
1
June 02, 2021
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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

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

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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