Plaque Disclosing Agent

What Is This Device?

Intended to enhance visualization of the presence of plaque on tooth surfaces.

How Is QJC Classified?

Plaque Disclosing Agent is FDA product code QJC, Class 1, 21 CFR 872.6855.

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.