DeviceClearance

Product code NXC— Dental

Clear Aligner

Classification name
Aligner, Sequential
Device class
Class 2
Regulation
21 CFR 872.5470
Advisory panel
Dental
Total cleared
145
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NXC under 21 CFR 872.5470, via openFDA

Market context for product code NXC

FDA has cleared 145 devices under product code NXC between 1998 and 2026, filed by 106 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NXC

Adverse events under product code NXC

product code NXC
Injury
15,206
Malfunction
2,576
Other
9
Total
17,791

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NXC

1–100 of 145

Data sourced from openFDA. This site is unofficial and independent of the FDA.