DeviceClearance

Product code PLH— Dental

OrthoPulse

Classification name
Orthodontic Led Accessory
Device class
Class 2
Regulation
21 CFR 872.5470
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

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.”

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

Market context for product code PLH

FDA has cleared 2 devices under product code PLH between 2015 and 2023, filed by 2 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

Top applicants under product code PLH

Recent clearances under product code PLH

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