Cleared Traditional

LightForce Orthodontic System

K232827 · Lightforce Orthodontics · Dental
Sep 2023
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K232827 is an FDA 510(k) clearance for the LightForce Orthodontic System, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Lightforce Orthodontics (Burlington, US). The FDA issued a Cleared decision on September 14, 2023, 1 days after receiving the submission on September 13, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K232827 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2023
Decision Date September 14, 2023
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NJM — Bracket, Ceramic, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470
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.