DEVICE: XPU MMOTOR NO LIGHT (J00716012440011)

Device Identifier (DI) Information

XPU MMOTOR NO LIGHT
1601244-001
In Commercial Distribution

BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
J00716012440011
HIBCC

1
338234588 *Terms of Use
The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedicated bur fixed to an adequate contra-angle or straight handpiece for different clinical applications. The micromotor connected to a cable or a hose depending on the type (the hose integrates water and air connection) is driven using an electronic control either integrated in a dental console or a dental unit.
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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?
66227 Dental surgical power tool motor, electric
A hand-held, electrically-powered component of a dental power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EFB Handpiece, Air-Powered, Dental
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FDA Premarket Submission

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

No
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

1c7f68c7-2a06-4b5f-9a4c-6f6c66ef8f83
May 02, 2024
1
April 24, 2024
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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
Yes
No
No
No CLOSE

Customer Contact

[?]
+1 949-477-6050
ba-usa@bienair.com
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