Guard, Disk

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Shandong.

Ascend Excellence Daily Products Jiangsu Co., Ltd. Jiangsu, contract manufacturer
Weihai Jieshi Commodity Manufacture Co., Ltd. Shandong

What Is FDA Product Code EEJ?

Guard, Disk is FDA product code EEJ, Class 1, 21 CFR 872.6010.

How Does It Reach the US Market?

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. It is also exempt from most of the quality system regulation.

Guard, Disk

The Orthodontic Store

Disc Guard

Guard, Disk

OrthoSafe sports guard / Assortment - The safe and comfortable guard for all types of sports / For further information please visit our online-shop on www.dentaurum.de

Guard, Disk

Who Makes This Device Type in China?

What Is FDA Product Code EEJ?

How Does It Reach the US Market?

The Orthodontic Store

Guard, Disk

Where China Actually Supplies