Product code NXC

Device name

Aligner, Sequential

Medical specialty

Dental

Device class

2

Regulation number

872.5470

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

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

Source

FDA openFDA device classification dataset