Carver, Dental Amalgam, Operative

How Is EKH Classified?

Carver, Dental Amalgam, Operative is FDA product code EKH, Class 1, 21 CFR 872.4565.

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 1 recall under this product code since 2017. None was by a company in China. The root cause the FDA records most often is Employee error (1).

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