The following data is part of a premarket notification filed by Shenzhen Carejoy Technology Co., Ltd. with the FDA for Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece.
|Device Name:||Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece|
|Classification||Handpiece, Air-powered, Dental|
|Applicant||Shenzhen Carejoy Technology Co., Ltd. 5 / F, Building E, No.10, East Snow Science And Technology, On Sakata Street, Longgang District Shenzhen, CN 518129|
Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, CN 518000
|CFR Regulation Number||872.4200 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|