PLH

Orthodontic Led Accessory

Product code

PLH

Device name

Orthodontic Led Accessory

Device class

Class 2

21 CFR

21 CFR 872.5470

Medical specialty

Dental

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

Definition text from the FDA device classification database (U.S. federal government work, public domain).