Dental High-speed Turbine Handpiece - The Dental High-speed Turbine Handpiece is the - Guangdong JINME Medical Technology Co., Ltd.

Duns Number:543260808

Device Description: The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patie The Dental High-speed Turbine 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.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).In order to avoid the risk, user must buy and use specified lubricant type “PANA SPRAY Plus” manufactured by NAKANISHI INC (cleared in K163483).

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More Product Details

Catalog Number

-

Brand Name

Dental High-speed Turbine Handpiece

Version/Model Number

T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170229

Product Code Details

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Device Record Status

Public Device Record Key

dc0abe19-c580-4498-9ba6-a28c614c353d

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

January 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2