Unit, X-Ray, Extraoral With Timer

How Is EHD Classified?

Unit, X-Ray, Extraoral With Timer is FDA product code EHD, Class 2, 21 CFR 872.1800.

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 10 clearances under this code; the FDA took a median of 100 days from receipt to decision on them.

One went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 1 was reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 18 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (3), Component design/selection (3) and Device Design (3).

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