NJMClass II

Bracket, Ceramic, Orthodontic

21 CFR 872.5470 / Dental

NJM is the FDA product code for Bracket, Ceramic, Orthodontic, a class II device type, regulated under 21 CFR 872.5470. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 60 510(k) clearances under this code, the most recent dated 2023-09-14, and one recall.

Classification record

Product code: NJM
Device name: Bracket, Ceramic, Orthodontic
FDA 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.
Regulation: 21 CFR 872.5470
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 60
Ingested recalls: 1

Clearances, product code NJM

By decision year

60 clearances under product code NJM with a decision year between 1990 and 2023, 2012 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code NJM by decision year
Year	Clearances
1990	1
1995	1
2004	2
2005	1
2006	2
2007	1
2008	4
2009	4
2010	1
2011	4
2012	6
2013	3
2014	1
2015	3
2016	3
2017	3
2018	4
2019	6
2020	2
2021	1
2022	2
2023	5

Applicants with the most clearances

Product code NJM

Applicants holding the most 510(k) clearances under product code NJM
Applicant	Clearances
American Orthodontics	3
Biocetec Co., Ltd.	3
CDB Corporation	3
LightForce Orthodontics	3
Ormco Corp.	3
3M UNITEK Corporation	2
Dentsply Interntional	2
Dentsply Intl.	2
Gni Co., Ltd.	2
Opal Orthodontics by Ultradent Products	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 47 companies shown, in name order