Camera, Cine, Endoscopic, With Audio

Which Manufacturers in China Make This?

3 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Hunan and Zhejiang.

Denjoy Dental Co., Ltd. Hunan, contract manufacturer
Dongguan Magenta Medical Equipment Co., Ltd. Guangdong
Tonglu Youshi Medical Instrument Co., Ltd. Zhejiang

How Is FTS Classified?

Camera, Cine, Endoscopic, With Audio is FDA product code FTS, Class 1, 21 CFR 878.4160.

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.

Camera, Cine, Endoscopic, With Audio

Adaptor ACC1 for footswitch 20010130

Camera, Cine, Endoscopic, With Audio

JMU

JMU Dental Intraoral Camera, 720P (1280x720 pixels), detachable, 8.2’/2.5m cable with metal connector

Camera, Cine, Endoscopic, With Audio

Telecam

TELECAM C-MOUNT 1-Chip Camera Head, NTSC

Camera, Cine, Endoscopic, With Audio

Catalogue number Ordinary model, standard model, luxury m, listed by Denjoy Dental Co., Ltd., China, under Camera, Cine, Endoscopic, With Audio. 3 manufacturers in China are registered for this product code.

Camera, Cine, Endoscopic, With Audio

Which Manufacturers in China Make This?

How Is FTS Classified?

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

Camera, Cine, Endoscopic, With Audio

JMU

Telecam

Intraoral Camera

Where China Actually Supplies