Intraoral Camera

Who Makes This Device Type in China?

6 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Zhejiang. 2 of them are contract manufacturers, able to build to a buyer’s own specification.

Dongguan Yipincheng Technology Co., Ltd. Guangdong
Guangdong Jinme Medical Technology Co., Ltd. Guangdong
Huizhou Videya Technology Co., Ltd. Guangdong
Ningbo Runyes Medical Instrument Co., Ltd. Zhejiang, contract manufacturer
Shenzhen Besdata Technology Co., Ltd. Guangdong
Shenzhen Xiazhifeng Electronic Co., Ltd. Guangdong, contract manufacturer

What Is It?

To capture the topographical characteristics of teeth or a stone model

How Is QJK Classified?

Intraoral Camera is FDA product code QJK, Class 2, 21 CFR 872.3661.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Intraoral Camera

Osstem Implant Co., Ltd.

This device is an oral camera device that can be magnified in the light of the inside of the mouth, and is used by dentists to photograph the inside of the mouth during oral examination. It…

Intraoral Camera