LightForce Orthodontic System

FDA 510(k) K232827 · Lightforce Orthodontics

Substantially Equivalent

510(k) numberK232827

Submission

Device name
LightForce Orthodontic System
Applicant
Lightforce Orthodontics
Burlington, MA, US
Received
September 13, 2023
Decision date
September 14, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
NJM – Bracket, Ceramic, Orthodontic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Specialty
Dental

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.

Other 510(k)s with product code NJM

510(k)DeviceApplicantDecision
K232011CleoNJM · Traditional American Orthodontics07/07/2023SE
K231635A-Line AdvancedNJM · Traditional Biocetec Co., Ltd.06/06/2023SE
K230225DynaFlex Clear Brackets & ButtonsNJM · Traditional Dyna Flex06/05/2023SE
K222847Ceramic Brackets OrthometricNJM · Traditional Orthometric - Industria E Comercio DE Produtos…05/04/2023SE
K222764LightForce Orthodontic SystemNJM · Special Lightforce Orthodontics09/14/2022SE
K220689Vatech ClismileNJM · Traditional Rayence Co., Ltd.05/06/2022SE
K201410VENUS Bracket, ROSE BracketNJM · Traditional Gni Co., Ltd.03/12/2021SE
K201038Luce Ceramic BracketNJM · Traditional Luce Castle Co., Ltd.10/09/2020SE
K200148LightForce Orthodontic System (LFO System)NJM · Traditional Lightforce Orthodontics02/21/2020SE
K182672ROSA BracketNJM · Traditional Gni Co., Ltd.11/15/2019SE

More from Gni Co., Ltd.

510(k)DeviceDecision
K222764LightForce Orthodontic SystemNJM · Special 09/14/2022SE
K200148LightForce Orthodontic System (LFO System)NJM · Traditional 02/21/2020SE

Questions and answers

When was LightForce Orthodontic System cleared by the FDA?

LightForce Orthodontic System (K232827) received a 510(k) decision of Substantially Equivalent on September 14, 2023, 1 days after the submission was received.

What is the product code of K232827?

The FDA product code is NJM – Bracket, Ceramic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.