Applicator, Rapid Wax, Dental
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Anhui, Guangdong and Shandong: 3 hold an FDA registration.
How Is EIT Classified?
Applicator, Rapid Wax, Dental is FDA product code EIT, Class 2, 21 CFR 872.3060.
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