DEVICE: MOT MC3 (J00716006800011)
Device Identifier (DI) Information
MOT MC3
1600680-001
In Commercial Distribution
1600680-001
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
1600680-001
In Commercial Distribution
1600680-001
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
No | |
No | |
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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? |
---|---|---|---|---|
38763 | Remotely-driven dental drilling system motor |
A mains electricity (AC-powered) compact motor used in conjunction with a spinning cable (e.g., a Bowden cable) to provide remote rotational power from the motor to a dental drill handpiece. This device is line-powered and cannot be sterilized. This is a reusable device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EFB | Handpiece, air-powered, dental |
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
c56c0ace-1753-4867-9ae1-43dea5ba48d7
October 26, 2022
3
June 17, 2021
October 26, 2022
3
June 17, 2021
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
[?]
+1 949-477-6050
ba-usa@bienair.com
ba-usa@bienair.com