Adhesive, Denture, Karaya
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Anhui.
- Wuhu Guli Ortho Co., Ltd. Anhui, contract manufacturer
What Is FDA Product Code KOP?
Adhesive, Denture, Karaya is FDA product code KOP, Class 1, 21 CFR 872.3450.
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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