DEVICE: Tur Black Pearl ECO 4H (J00716000400011)
Device Identifier (DI) Information
Tur Black Pearl ECO 4H
1600040-001
In Commercial Distribution
1600040-001
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
1600040-001
In Commercial Distribution
1600040-001
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
Turbines are intended to generate rotating mechanical energy from compressed air
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? |
---|---|---|---|---|
40958 | Dental power tool system handpiece, pneumatic |
A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
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
2e1b9d23-29a9-4058-a084-4a2932f859ab
October 26, 2022
2
June 17, 2021
October 26, 2022
2
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 |
---|---|---|---|---|---|
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