Luminesse Multi-Layer Pmma Discs
Catalogue number 5320D4, listed by Talladium, Inc., United States, under Coating, Denture Hydrophilic, Resin. 1 manufacturer in China is registered for this product code.
Coating, Denture Hydrophilic, Resin
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Henan.
- Zhengzhou Huaer Electro-Optics Technology Co., Ltd. Henan, contract manufacturer
What Is FDA Product Code EBE?
Coating, Denture Hydrophilic, Resin is FDA product code EBE, Class 2, 21 CFR 872.3300.
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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