Orthodontic Software

What Is This Device?

The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.

What Is FDA Product Code PNN?

Orthodontic Software is FDA product code PNN, Class 2, 21 CFR 872.5470.

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. 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 202 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2021. None was by a company in China. The root causes the FDA records most often are Software design (1) and Process control (1).

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