Bracket, Ceramic, Orthodontic
FDA product code NJM · Class II (moderate risk) · 21 CFR 872.5470 · 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.
60510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Biocetec Co., Ltd. 3
- Tomy, Inc. 3
- American Orthodontics 3
- Ormco Corp. 3
- Cdb Corporation 3
- Lightforce Orthodontics 3
- Dentsply Interntional 2
- Orthodontic Design and Production, Inc. 2
- World Bio Tech Co., Ltd. 2
- Opal Orthodontics by Ultradent Products, Inc. 2
- Ortho Organizers, Inc. 2
- Signature Orthodontics 2
- Ortho Technology, Inc. 2
- 3M Unitek 2
- Gni Co., Ltd. 2
- Dentsply Intl. 2
- TP Orthodontics, Inc. 2
- Forestadent Bernhard Forster GmbH 1
- Dyna Flex 1
- Star Dentech Korea., Corp 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232827 | LightForce Orthodontic SystemNJM · Traditional | Lightforce Orthodontics | 09/14/2023SE |
| K232011 | CleoNJM · Traditional | American Orthodontics | 07/07/2023SE |
| K231635 | A-Line AdvancedNJM · Traditional | Biocetec Co., Ltd. | 06/06/2023SE |
| K230225 | DynaFlex Clear Brackets & ButtonsNJM · Traditional | Dyna Flex | 06/05/2023SE |
| K222847 | Ceramic Brackets OrthometricNJM · Traditional | Orthometric - Industria E Comercio DE Produtos… | 05/04/2023SE |
| K222764 | LightForce Orthodontic SystemNJM · Special | Lightforce Orthodontics | 09/14/2022SE |
| K220689 | Vatech ClismileNJM · Traditional | Rayence Co., Ltd. | 05/06/2022SE |
| K201410 | VENUS Bracket, ROSE BracketNJM · Traditional | Gni Co., Ltd. | 03/12/2021SE |
| K201038 | Luce Ceramic BracketNJM · Traditional | Luce Castle Co., Ltd. | 10/09/2020SE |
| K200148 | LightForce Orthodontic System (LFO System)NJM · Traditional | Lightforce Orthodontics | 02/21/2020SE |
| K182672 | ROSA BracketNJM · Traditional | Gni Co., Ltd. | 11/15/2019SE |
| K192202 | Clear21NJM · Traditional | World Class Technology Corporation | 11/12/2019SE |
| K190608 | Mei Ceramic BracketNJM · Traditional | Orthosun Co., Ltd. | 11/04/2019SE |
| K180952 | Ceramic BracketNJM · Traditional | Mem Dental Technology Co., Ltd. | 06/07/2019SE |
| K182193 | S-LineNJM · Traditional | Biocetec Co., Ltd. | 01/22/2019SE |
| K183542 | Signature Orthodontic SystemNJM · Traditional | Signature Orthodontics | 01/02/2019SE |
| K181271 | Signature Orthodontic SystemNJM · Traditional | Signature Orthodontics | 06/13/2018SE |
| K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance SystemNJM · Traditional | 3M Healthcare | 03/16/2018SE |
| K173440 | Carriere SLX 3D ClearNJM · Traditional | Ortho Organizers, Inc. | 03/08/2018SE |
| K172845 | Symetri ClearNJM · Traditional | Ormco Corporation | 01/31/2018SE |
| K171844 | Inspire ICE aka Inspire ICE Clear BracketsNJM · Traditional | Ormco Corporation | 07/18/2017SE |
| K163467 | C-Line Orthodontic Ceramic BracketNJM · Traditional | Biocetec Co., Ltd. | 06/14/2017SE |
| K163117 | Alpha PureNJM · Traditional | Koroad America | 05/09/2017SE |
| K160957 | CDB Self Ligating Bracket 8FNJM · Traditional | Cdb Corporation | 09/27/2016SE |
| K160615 | Orthodontic Ceramic Brackets 1.1NJM · Traditional | Tomy, Inc. | 08/26/2016SE |
| K152167 | BIJOU Orthodontic Ceramic BracketNJM · Traditional | World Bio Tech Co., Ltd. | 05/27/2016SE |
| K152779 | Avex CX2NJM · Special | Opal Orthodontics by Ultradent Products | 11/25/2015SE |
| K150141 | Orthodontics BracketNJM · Traditional | Speed Dental Co., Ltd. | 10/23/2015SE |
| K142729 | Chi Lites Orthodontic Sapphire BracketNJM · Traditional | Progressive Technology, Inc. | 05/15/2015SE |
| K141104 | Truklear BracketNJM · Special | Ajw Technology Consultants, Inc. | 06/25/2014SE |
| K132368 | Vapor Ceramic BracketNJM · Traditional | Orthodontic Design and Production, Inc. | 12/19/2013SE |
| K131197 | Edgewise Ceramic Brackets, Roth Ceramic BracketsNJM · Traditional | Dental Morelli | 08/27/2013SE |
| K130446 | Fastbraces Ceramic BracketsNJM · Traditional | Orthodontic Design and Production, Inc. | 06/07/2013SE |
| K123092 | Ceramin Brackets ZNJM · Traditional | Tomy, Inc. | 12/21/2012SE |
| K122753 | Empower ClearNJM · Traditional | American Orthodontics | 12/14/2012SE |
| K123094 | Orthodontic Ceramic BracketsNJM · Traditional | Tomy, Inc. | 12/13/2012SE |
| K120471 | Mach Brackets Bright BracketsNJM · Traditional | World Bio Tech Co., Ltd. | 06/04/2012SE |
| K113334 | Avex CX2 and Avex CXI2 Ceramic BracketsNJM · Traditional | Opal Orthodontics by Ultradent Products, Inc. | 02/03/2012SE |
| K112707 | Generation C Aesthetic Self-Ligating Bracket SystemNJM · Traditional | Ortho Technology, Inc. | 01/13/2012SE |
| K110335 | Ceramic BracketsNJM · Traditional | Ortho Organizers, Inc. | 05/19/2011SE |
| K111234 | Click-ItNJM · Traditional | Tp Orthodontics, Inc. | 05/13/2011SE |
| K102803 | Clarity Advanced Ceramic BracketsNJM · Traditional | 3M Unitek Corporation | 02/17/2011SE |
| K102561 | Orthodontic Ceramic BracketNJM · Traditional | Ht Co., Ltd. | 01/25/2011SE |
| K101481 | Biomers Translucent Orthodontic BracketNJM · Traditional | Biomers Products, LLC | 06/23/2010SE |
| K091702 | CDB Flip-Side-Clip BracketNJM · Traditional | Cdb Corporation | 08/07/2009SE |
| K090933 | Bernhard-Forster GmbH Orthodontic Ceramic BracketsNJM · Traditional | Forestadent Bernhard Forster GmbH | 06/05/2009SE |
| K090567 | Orthodontic Ceramic BracketNJM · Traditional | Star Dentech Korea., Corp | 05/27/2009SE |
| K090454 | Allure MB Ceramic BracketsNJM · Special | Dentsply Interntional | 03/20/2009SE |
| K082974 | Mystique MB Ceramic BracketsNJM · Special | Dentsply Interntional | 11/07/2008SE |
| K080906 | CDB ClipNJM · Traditional | Cdb Corporation | 10/17/2008SE |
| K081415 | Damon 4CLEARNJM · Traditional | Ormco Corp. | 09/24/2008SE |
| K080749 | RadianceNJM · Traditional | American Orthodontics | 08/04/2008SE |
| K073045 | Sapphire Ceramic BracketNJM · Traditional | Ortho Technology, Inc. | 12/18/2007SE |
| K062305 | Clarity Modified Ceramic BracketsNJM · Traditional | 3M Unitek | 10/18/2006SE |
| K060837 | In-Ovation CNJM · Special | Dentsply International | 04/10/2006SE |
| K052245 | Accent and Exceed Series Orthodontic Ceramic BracketsNJM · Traditional | Lar Mfg., LLC | 09/23/2005SE |
| K042905 | Neo-Clip Orthodontic Bracket AccessoryNJM · Special | Dentsply Intl. | 11/04/2004SE |
| K042178 | Orthodontic Ceramic BracketsNJM · Special | Dentsply Intl. | 08/30/2004SE |
| K950992 | Ceramaflex Bracket SystemNJM · Traditional | Tp Orthodontics, Inc. | 05/03/1995SE |
| K902075 | Intrigue Ceramic BracketNJM · Traditional | Lancer Orthodontics, Inc. | 08/06/1990SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0481-2014 Class III | Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic…Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design… | Ultradent Products, Inc. | 11/19/2013Terminated |