External Cleaning Solution

What Is It?

For use on dental restorations, external to the mouth, prior to insertion into the mouth.

How Is PME Classified?

External Cleaning Solution is FDA product code PME, Class 2, 21 CFR 872.3260.

What Does It Take to Sell It in the United States?

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.