Search Results
Found 4 results
510(k) Data Aggregation
K Number
K240337Device Name
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
Manufacturer
Guangdong JINME Medical Technology Co., Ltd.
Date Cleared
2024-11-13
(282 days)
Product Code
EFB, EGS, KMW
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Guangdong JINME Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Model J6-126, J6-136:
The Dental Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
For Model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L:
The Dental Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.
Device Description
The Dental Handpiece is mainly composed of a machine head, handle, transmission shaft, and cartridge, and is designed to be attached to the drive via standard coupling which complies with ISO 3964 and hose connector which complies with ISO 9168. The head clamp accepts an instrument complying with ISO 1797-1. The handpieces are intended to be powered by air-powered or electric-powered, and they are also intended to provide optic series. They are intended to be provided non-sterile, so they must be sterilized prior to first use and sterilized after each subsequent use using steam sterilization (moist heat sterilization).
Ask a Question
K Number
K240340Device Name
Surgical Drive System (Model: ES70, ES90, E8)
Manufacturer
Guangdong Jinme Medical Technology Co., Ltd.
Date Cleared
2024-07-18
(164 days)
Product Code
DZI, ERL
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
Guangdong Jinme Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Drive System (Model: ES70, ES90, E8) is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery
Device Description
The Surgical Drive System is an electrical drive unit, including a motor, power console, foot control, connection cables, and other accessories. It is intended for use in surgical procedures involving incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone. The basic function of the Surgical Drive System is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters. The foot control is used for activation of the motor and changing parameters e.g. program, pump state, and motor direction. The motor's function is to provide power for handpieces with the gear ratio (1:1, 1:4.2, 1:5, 3.2:1, 3.4:1, 40:1), the Max. speed of the motor is 40000 min-1, and it is designed with an ISO 3964 Type 3 connector.
Ask a Question
K Number
K170236Device Name
Dental Low-speed Turbine Handpiece
Manufacturer
Guangdong JINME Medical Technology Co., Ltd.
Date Cleared
2017-11-21
(300 days)
Product Code
EFB, EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Guangdong JINME Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental Low-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Device 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 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.
Ask a Question
K Number
K170229Device Name
Dental High-speed Turbine Handpiece
Manufacturer
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
Date Cleared
2017-11-08
(287 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental High-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Device Description
The Dental High-speed Turbine Handpiece is the dental treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector. 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 and efficiency can be improved. Cartidges have high precision when rotating, cartiridges 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). In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).
Ask a Question
Page 1 of 1