FDA Product Code NJM: Bracket, Ceramic, Orthodontic
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.
Leading manufacturers include Lightforce Orthodontics, Gni Co., Ltd. and Dentsply Intl..
60
Total
60
Cleared
111d
Avg days
1990
Since
Declining activity -
0 submissions in the last 2 years
vs 6 in the prior period
FDA 510(k) Cleared Bracket, Ceramic, Orthodontic Devices (Product Code NJM)
60 devices
Cleared
Sep 14, 2023
LightForce Orthodontic System
Lightforce Orthodontics
Dental
1d
Cleared
Jul 07, 2023
Cleo
American Orthodontics
Dental
1d
Cleared
Jun 06, 2023
A-Line Advanced
Biocetec Co., Ltd.
Dental
1d
Cleared
Jun 05, 2023
DynaFlex Clear Brackets & Buttons
Dyna Flex
Dental
129d
Cleared
May 04, 2023
Ceramic Brackets Orthometric
Orthometric - Industria E Comercio DE Produtos Medicos
Dental
225d
Cleared
Sep 14, 2022
LightForce Orthodontic System
Lightforce Orthodontics
Dental
1d
Cleared
May 06, 2022
Vatech Clismile
Rayence Co., Ltd.
Dental
58d
Cleared
Mar 12, 2021
VENUS Bracket, ROSE Bracket
Gni Co., Ltd.
Dental
288d
Cleared
Oct 09, 2020
Luce Ceramic Bracket
Luce Castle Co., Ltd.
Dental
172d
Cleared
Feb 21, 2020
LightForce Orthodontic System (LFO System)
Lightforce Orthodontics
Dental
30d
Cleared
Nov 15, 2019
ROSA Bracket
Gni Co., Ltd.
Dental
415d
Cleared
Nov 12, 2019
Clear21
World Class Technology Corporation
Dental
90d
Cleared
Nov 04, 2019
Mei Ceramic Bracket
Orthosun Co., Ltd.
Dental
238d
Cleared
Jun 07, 2019
Ceramic Bracket
Mem Dental Technology Co., Ltd.
Dental
422d
Cleared
Jan 22, 2019
S-Line
Biocetec Co., Ltd.
Dental
161d
Cleared
Jan 02, 2019
Signature Orthodontic System
Signature Orthodontics
Dental
13d
Cleared
Jun 13, 2018
Signature Orthodontic System
Signature Orthodontics
Dental
30d
Cleared
Mar 16, 2018
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
3M Healthcare
Dental
30d
Cleared
Mar 08, 2018
Carriere SLX 3D Clear
Ortho Organizers, Inc.
Dental
122d
Cleared
Jan 31, 2018
Symetri Clear
Ormco Corporation
Dental
134d
Cleared
Nov 04, 2004
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
Dentsply Intl.
Dental
14d
Cleared
Aug 30, 2004
ORTHODONTIC CERAMIC BRACKETS
Dentsply Intl.
Dental
19d
About Product Code NJM - Regulatory Context
510(k) Submission Activity
60 total 510(k) submissions under product code NJM since 1990, with 60 receiving FDA clearance (average review time: 111 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 6 in the prior period.