Adhesive, Denture, Acacia and Karaya With Sodium Borate
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Hunan and Zhejiang.
- Changsha Easyinsmile Intelligence Technology Co., Ltd. Hunan
- Hangzhou Wise Medical Device Co., Ltd. Zhejiang, contract manufacturer
How Is KOM Classified?
Adhesive, Denture, Acacia And Karaya With Sodium Borate is FDA product code KOM, Class 1, 21 CFR 872.3400.
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.
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