Cushion, Pad, Denture, Wax Impregnated Cotton, Over the Counter
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shanghai and Guangdong, and 1 other province: 6 hold an FDA registration. 1 is a contract manufacturer.
- Debo Medical Technology (Shijiazhuang) Co., Ltd. Hebei, contract manufacturer
- Guangzhou Nuoning Medical Supplies Co., Ltd. Guangdong, contract manufacturer
- Shanghai Hua En Industrial Co Ltd Shanghai, contract manufacturer
- Unisource Shanghai Ltd. Shanghai
- Wuxi Lyusmile IMP AND EXP Co., Ltd. Jiangsu
- Zogear Medical Co., Ltd. Jiangsu, contract manufacturer
What Is This Device?
OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day’s use.
What Is FDA Product Code NKJ?
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter is FDA product code NKJ, Class 1, 21 CFR 872.3540.
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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