DEVICE: Dental Low-speed Turbine Handpiece (06971119540029)
Device Identifier (DI) Information
Dental Low-speed Turbine Handpiece
LN, L
In Commercial Distribution
Guangdong JINME Medical Technology Co., Ltd.
LN, L
In Commercial Distribution
Guangdong JINME Medical Technology Co., Ltd.
The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model LN and L. The device description of the Dental Low-speed Handpiece is as following:
The gear ratios of handpieces have various gear ratios (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase));
The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm.
The air motors are capable of running up to a speed of 22000 rpm, but different at different pressure of air supply; refer to section 2.3 for details.
The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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 |
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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K170236 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
4d111f6b-a740-43d5-bb9e-b82f16115a62
November 22, 2018
4
January 16, 2018
November 22, 2018
4
January 16, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Unit of Use DI
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Unit of Use DI Number:
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined