Y-Kelin
Products Name: Y-Kelin Denture Adhesive Cushion Upper 30 pad + Lower 30 pads Specification: Upper 30 pieces/box + Lower 30 pieces/box Composition: Sodium alginate, Polyester fiber, Viscose…
Cushion, Denture, Over the Counter
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Anhui and Shanghai: 2 hold an FDA registration.
What Is FDA Product Code EHS?
Cushion, Denture, Over The Counter is FDA product code EHS, Class 2, 21 CFR 872.3540.
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.
Name
Record