Capsule, Dental, Amalgam
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Hebei and Jiangsu: 2 hold an FDA registration.
- Debo Medical Technology (Shijiazhuang) Co., Ltd. Hebei, contract manufacturer
- Tribest Dental Products Co Ltd Jiangsu, contract manufacturer
How Is DZS Classified?
Capsule, Dental, Amalgam is FDA product code DZS, Class 1, 21 CFR 872.3110.
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.
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