Cleared Special

K222764 - LightForce Orthodontic System
(FDA 510(k) Clearance)

K222764 · Lightforce Orthodontics · Dental
Sep 2022
Decision
1d
Days
Class 2
Risk

K222764 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, 2022, 1 days after receiving the submission on September 13, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K222764 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2022
Decision Date September 14, 2022
Days to Decision 1 days
Submission Type Special
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.