Tissue Culture, Accessories, Dental
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.
What Is This Device?
Intended to temporarilty nourish cells on an avulsed tooth
How Is NVG Classified?
Tissue Culture, Accessories, Dental is FDA product code NVG, Class 1, 21 CFR 864.2240.
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. It is also exempt from most of the quality system regulation.