Dental Low-Speed Turbine Handpiece

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…

Registry build 21.09.26

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).

10manufacturers in China registered for this device type
3catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (7), Guangxi (1), Shaanxi (1).

Chinese manufacturers registered for FDA product code EFB
Manufacturer City Province Registered as Device types
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Foshan Coxo Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 19
Foshan Cicada Dental Instrument Co., Ltd. Foshan Guangdong Manufacturer 15
Guangdong Jinme Medical Technology Co., Ltd. Foshan Guangdong Manufacturer 13
Sinol Dental Limited Xianyang Shaanxi Manufacturer 5
Foshan Soco Precision Instrument Co., Ltd. Foshan Guangdong Manufacturer 4
Shanghai Dental Instrument Factory Co., Ltd. Shanghai Shanghai Manufacturer 3
Foshan Topmed Dental Co., Ltd. Foshan Guangdong Manufacturer 2
Foshan Wenjian Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 2
Litu Tech Ltd. Zhongshan Guangdong Manufacturer 1

Record

Regulatory record for Dental Low-speed Turbine Handpiece
Listed by Guangdong Jinme Medical Technology Co., Ltd., China
FDA product code EFB
Device type Handpiece, Air-Powered, Dental
Device class Class 1
Regulation 21 CFR 872.4200
Establishment Manufacturer
510(k) K170236
Record published 2018-01-16
Record revised 2018-11-22 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Dental Low-speed Turbine Handpiece
Catalogue number Size Status
LN, L In distribution
LN In distribution
L In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
AIR-Flow E.M.S. Electro Medical Systems S.A. 220
Lares Research Lares Research 130
MK-dent MK-dent GmbH 129
Vector R&D, Inc Vector R&D, Inc. 114
MK-dent Germany® MK-dent GmbH 112
Johnson-Promident Young Innovations Inc. 92
Brasseler USA Peter Brasseler Holdings, LLC 76
Airlight Beyes Dental Canada, Inc. 65
Henry Schein Henry Schein, Inc. 62
MicroP Dental Microp Technology (Taiwan), Inc. 51
StarDental Instrument Solutions Dentalez, Inc. 47
Air-Driven Dental Handpieces MDK Co., Ltd. 39

Showing 12 of 968. All products under Handpiece, Air-Powered, Dental

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K240337 2024-11-13
K170236 2017-11-21
K170229 2017-11-08

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer