Handpiece, Contra- and Right-Angle Attachment, Dental

What Is FDA Product Code EGS?

Handpiece, Contra- And Right-Angle Attachment, Dental is FDA product code EGS, Class 1, 21 CFR 872.4200.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 3 clearances under this code; the FDA took a median of 89 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2015. None was by a company in China. The root cause the FDA records most often is Packaging process control (1).

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