Crown, Preformed

What Is FDA Product Code ELZ?

Crown, Preformed is FDA product code ELZ, Class 1, 21 CFR 872.3330.

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.

What Has Gone Wrong With It?

The FDA has recorded 4 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Process control (2) and Packaging process control (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.