Tube Impression and Matrix

What Is FDA Product Code KCQ?

Tube Impression And Matrix is FDA product code KCQ, Class 1, 21 CFR 872.6570.

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.