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Dental Low-speed Turbine Handpiece

Guangdong JINME Medical Technology Co., Ltd. · Model LN, L · UDI-DI 06971119540029

EFB

510(k) clearances

2,300

Adverse events

Recalls

Facilities

Description

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).

Recalls

Date	Firm	Reason
2023-01-20	Coltene Whaledent Inc	Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines hea
2016-07-08	Nakanishi Inc.	Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that
2012-05-07	MTI Precision Products LLC.	Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.
2006-11-22	Kavo America Corporation	The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may
2003-10-14	DentSply -Professional Division	Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
2003-10-14	DentSply -Professional Division	Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
2003-10-14	DentSply -Professional Division	Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
2003-10-14	DentSply -Professional Division	Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.