X-Ray, Tomography, Computed, Dental

What Is It?

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

What Is FDA Product Code OAS?

X-Ray, Tomography, Computed, Dental is FDA product code OAS, Class 2, 21 CFR 892.1750.

What Does It Take to Sell It in the United States?

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. Chinese applicants hold 9 clearances under this code; the FDA took a median of 114 days from receipt to decision on them. 3 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 7 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Radiation Control for Health and Safety Act (5) and Device Design (1).

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