PLH — Orthodontic Led Accessory Class II

FDA Device Classification

Classification Details

Product Code: PLH
Device Class: Class II
Regulation Number: 872.5470
Submission Type
Review Panel: DE
Medical Specialty: Dental
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K230905	biolux technology	OrthoPulse 2.0E (OPi2E-100)	June 9, 2023
K143120	biolux research	OrthoPulse	July 24, 2015