DeviceClearance

Product code NJM— Dental

LightForce Orthodontic System

Classification name
Bracket, Ceramic, Orthodontic
Device class
Class 2
Regulation
21 CFR 872.5470
Advisory panel
Dental
Total cleared
60
First cleared
Most recent

FDA classification definition

“An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.”

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

Market context for product code NJM

FDA has cleared 60 devices under product code NJM between 1990 and 2023, filed by 40 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 NJM

Recent clearances under product code NJM

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