Aligner, Sequential

What Is This Device?

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

What Is FDA Product Code NXC?

Aligner, Sequential is FDA product code NXC, Class 2, 21 CFR 872.5470.

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 12 clearances under this code; the FDA took a median of 201 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.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2024. None was by a company in China. The root causes the FDA records most often are Software design (manufacturing process) (1) and Device Design (1).

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