DEVICE: Zibone (04710986432622)
Device Identifier (DI) Information
Zibone
Me-D4822
In Commercial Distribution
COHO BIOMEDICAL TECHNOLOGY CO., LTD.
Me-D4822
In Commercial Distribution
COHO BIOMEDICAL TECHNOLOGY CO., LTD.
Implant Adaptor
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? |
---|---|---|---|---|
63511 | Dental power tool converter attachment, rotary |
A dental attachment, commonly known as a ratchet adaptor, drive converter, or dental turbine, designed to be fitted in a dental power tool handpiece to convert energy (e.g., electrical, pneumatic) to a rotational mechanical motion to achieve a specific function [e.g., drilling] during dental or orthodontic procedures. It is not an endpiece; an appropriate interchangeable endpiece (e.g., drill bit, dental bur) is intended to be fixed to the working end of this device. This is a reusable device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NDP | Accessories, Implant, Dental, Endosseous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
36287019-5315-4442-9b31-7cf7e792b5f1
May 11, 2020
1
May 01, 2020
May 11, 2020
1
May 01, 2020
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