DEVICE: AG Neovo (04710739590197)
Device Identifier (DI) Information
AG Neovo
REVOLUTION R-5510
In Commercial Distribution
ASSOCIATED INDUSTRIES CHINA, INC.
REVOLUTION R-5510
In Commercial Distribution
ASSOCIATED INDUSTRIES CHINA, INC.
Dental Low-speed Handpieces and Accessories
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? |
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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 |
45572 | Dental power tool system, line-powered |
An assembly of devices designed to both bore/excavate and saw bones, teeth, and tough tissues during a dental/maxillofacial surgical procedure. It typically consists of a motorized handpiece and/or motor, a control unit, and a variety of attachments used to hold the cutting instruments (e.g., drill bits, saw blades, burs, polishing disks). The system is electrically-powered from the mains (e.g., 230 or 115 volt) and supplies the handpiece/motor with low-voltage electricity (e.g., 24 volt) through the control unit. The system may operate through a dental delivery system or be freestanding and independent. 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 |
EGS | Handpiece, Contra- And Right-Angle Attachment, 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
bdded95c-9644-41da-bfcd-90f4cc2f0374
December 27, 2021
1
December 17, 2021
December 27, 2021
1
December 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
[?]
No Customer Contact currently defined