Therapeutic devices · 21 CFR 872 Subpart F
Orthodontic Ceramic Bracket
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.
- Companies listing it
- 4229 makers
- Brands and models
- 104
- 510(k) clearances
- 607 in five years
- FDA name
- Bracket, Ceramic, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list NJM
42 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sybron Dental Specialties | United States | Maker | — | 203 | 2026 |
| American Orthodontics | United States | Maker | Cleo · Empower Clear®, Empower® 2 Clear · Radiance Plus® | 44 | 2026 |
| LightForce Orthodontics, Inc | United States | Maker | LightForce Orthodontic System · Signature Orthodontics | 3 | 2023 |
| Cdb Corporation | United States | Maker | CDB Clip · CDB Flip-Slide-Clip Bracket | 9 | 2022 |
| Ortho Organizers, Inc. | United States | Maker | Carriere SLX 3D Clear · NeoCrystal Plus · NeoLucent Plus · PURE | 8 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | ClearVu · ClearVu with pre-applied adhesive · Click-It Self Ligating Bracket · InVu · +4 | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | AQUA/Ceramic brackets | 4 | 2025 |
| Mem Dental Technology Co., Ltd. | Taiwan | Maker | — | 2 | 2025 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | QuicKlear -Brackets · TruKlear Brackets | 4 | 2011 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| GNI Co., LTD | South Korea | Maker | ROSA Bracket · VENUS Bracket, ROSE Bracket | 3 | 2021 |
| G&H Wire Company | United States | Maker | AGILITY · aneav · FASTBRACES · Plastic Brackets (Pattern) · +4 | 2 | 2008 |
| GC Orthodontics | United States | Maker | CHIC Brackets | 2 | 2015 |
| World Bio Tech Co Ltd | South Korea | Maker | BIJOU Orthodontic Ceramic Bracket · SELPRO BRACKET BRIGHT BRACKET | 2 | 2016 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| HT Co., Ltd. | South Korea | Maker | — | 1 | 2011 |
| World Class Technology Corporation | United States | Maker | Clear21 | 1 | 2019 |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Maker | ICE CLEAR · ICERAM · ICERAM-P | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | eXceed | — | — |
| Aditek do Brasil SA | Brazil | Maker | Active Clear · Active Clear+ · BioCrystal · EasyClip Clear · +3 | — | — |
| OSSTEM ORTHODONTICS Inc. | South Korea | Maker | Clear Elect · Genesis- C · MAJESTY-SLC · Neocrystal Plus · +2 | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Ortho Solutions LC | United States | Maker | Norris Clear System | — | — |
| Garnet Dentech | South Korea | Maker | ORTHODONTIC CERAMIC BRACKET | — | — |
| Ortho Attachyhook Supply LTD. | Canada | Maker | Ceramic Bracket | — | — |
| SPT Roth Ltd. | Switzerland | Maker | ceramic, orthodontic bracket · Clarity Advanced Ceramic Brackets · Clarity SL | — | — |
| Calibaja Manufacturing, S.A. de C.V. | Mexico | Maker | — | — | — |
| MPL Manufacturing Inc. | United States | Maker | — | — | — |
| TOSOH Corporation | Japan | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Accent Brackets · Bracket | 23 | 2025 |
| Rmo, Inc. | United States | Manufacturer | Fli Clear M · FLI CSL; Signature ceramic bracket | 1 | 1990 |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | — | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Glace- Crystal Sapphire Bracket System MBT slot 18 · Glace- Crystal Sapphire Bracket System MBT slot 22 · Glace- Crystal Sapphire Bracket System Roth slot 18 · Glace- Crystal Sapphire Bracket System Roth slot 22 · +11 | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Phantom · Phantom LP · Phantom Luxe | — | — |
| Orthoworld, L.L.C. | United States | Repacker / relabeler | FASTBRACES® CLASSIC CLEAR LL/LR 1/2 · FASTBRACES® CLASSIC CLEAR LL3 · FASTBRACES® CLASSIC CLEAR LR3 · FASTBRACES® CLASSIC CLEAR U/L 4/5 · +9 | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Nova C, Nova S | — | — |
| Csy International LLC | United States | Repacker / relabeler | Claro · J&J Ortho · J&J ORTHODONTICS · NIEVE | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | BRACKET, CERAMIC, ORTHODONTIC | — | — |
| Fairfield Orthodontics, LLC | United States | Repacker / relabeler | SMILES CERAMIC BRACKETS | — | — |
| Midwest Dental | United States | Repacker / relabeler | Advance Pure Ice · Advance Pure Ice S | — | — |
| Tangent Technologies LLC | United States | Contract manufacturer | Ceramic Orthodontic Brackets | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 14 Sep 2023 | K232827 | LightForce Orthodontic System | LightForce Orthodontics, Inc |
| 7 Jul 2023 | K232011 | Cleo | American Orthodontics |
| 6 Jun 2023 | K231635 | A-Line Advanced | Biocetec Co., Ltd. |
| 5 Jun 2023 | K230225 | DynaFlex Clear Brackets & Buttons | Dyna Flex |
| 4 May 2023 | K222847 | Ceramic Brackets Orthometric | Orthometric - Industria E Comercio DE Produtos Medicos |
| 14 Sep 2022 | K222764 | LightForce Orthodontic System | LightForce Orthodontics, Inc |
| 6 May 2022 | K220689 | Vatech Clismile | Rayence Co., Ltd. |
| 12 Mar 2021 | K201410 | VENUS Bracket, ROSE Bracket | GNI Co., LTD |
| 9 Oct 2020 | K201038 | Luce Ceramic Bracket | Luce Castle Co., Ltd. |
| 21 Feb 2020 | K200148 | LightForce Orthodontic System (LFO System) | LightForce Orthodontics, Inc |
| 15 Nov 2019 | K182672 | ROSA Bracket | GNI Co., LTD |
| 12 Nov 2019 | K192202 | Clear21 | World Class Technology Corporation |
| 4 Nov 2019 | K190608 | Mei Ceramic Bracket | Orthosun Co., Ltd. |
| 7 Jun 2019 | K180952 | Ceramic Bracket | Mem Dental Technology Co., Ltd. |
| 22 Jan 2019 | K182193 | S-Line | Biocetec Co., Ltd. |
| 2 Jan 2019 | K183542 | Signature Orthodontic System | Signature Orthodontics |
| 13 Jun 2018 | K181271 | Signature Orthodontic System | Signature Orthodontics |
| 16 Mar 2018 | K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | 3M Healthcare |
| 8 Mar 2018 | K173440 | Carriere SLX 3D Clear | Ortho Organizers, Inc. |
| 31 Jan 2018 | K172845 | Symetri Clear | Sybron Dental Specialties |
| 18 Jul 2017 | K171844 | Inspire ICE aka Inspire ICE Clear Brackets | Sybron Dental Specialties |
| 14 Jun 2017 | K163467 | C-Line Orthodontic Ceramic Bracket | Biocetec Co., Ltd. |
| 9 May 2017 | K163117 | Alpha Pure | Koroad America |
| 27 Sep 2016 | K160957 | CDB Self Ligating Bracket 8F | Cdb Corporation |
| 26 Aug 2016 | K160615 | ORTHODONTIC CERAMIC BRACKETS 1.1 | Tomy, Inc. |
| 27 May 2016 | K152167 | BIJOU Orthodontic Ceramic Bracket | World Bio Tech Co Ltd |
| 25 Nov 2015 | K152779 | Avex CX2 | Opal Orthodontics by Ultradent Products |
| 23 Oct 2015 | K150141 | Orthodontics Bracket | Speed Dental Co., Ltd. |
| 15 May 2015 | K142729 | Chi Lites Orthodontic Sapphire Bracket | Progressive Technology, Inc. |
| 25 Jun 2014 | K141104 | TRUKLEAR BRACKET | Ajw Technology Consultants, Inc. |
| 19 Dec 2013 | K132368 | VAPOR CERAMIC BRACKET | Orthodontic Design and Production, Inc. |
| 27 Aug 2013 | K131197 | EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS | Dental Morelli |
| 7 Jun 2013 | K130446 | FASTBRACES CERAMIC BRACKETS | Orthodontic Design and Production, Inc. |
| 21 Dec 2012 | K123092 | CERAMIN BRACKETS Z | Tomy, Inc. |
| 14 Dec 2012 | K122753 | EMPOWER CLEAR | American Orthodontics |
| 13 Dec 2012 | K123094 | ORTHODONTIC CERAMIC BRACKETS | Tomy, Inc. |
| 4 Jun 2012 | K120471 | MACH BRACKETS BRIGHT BRACKETS | World Bio Tech Co Ltd |
| 3 Feb 2012 | K113334 | AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS | Opal Orthodontics by Ultradent Products |
| 13 Jan 2012 | K112707 | GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM | Ortho Technology, Inc. |
| 19 May 2011 | K110335 | CERAMIC BRACKETS | Ortho Organizers, Inc. |
| 13 May 2011 | K111234 | CLICK-IT | Tp Orthodontics, Inc. |
| 17 Feb 2011 | K102803 | CLARITY ADVANCED CERAMIC BRACKETS | 3M Unitek Corporation |
| 25 Jan 2011 | K102561 | ORTHODONTIC CERAMIC BRACKET | HT Co., Ltd. |
| 23 Jun 2010 | K101481 | BIOMERS TRANSLUCENT ORTHODONTIC BRACKET | Biomers Products, LLC |
| 7 Aug 2009 | K091702 | CDB FLIP-SIDE-CLIP BRACKET | Cdb Corporation |
| 5 Jun 2009 | K090933 | BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS | Forestadent Bernhard Forster GmbH |
| 27 May 2009 | K090567 | ORTHODONTIC CERAMIC BRACKET | Star Dentech Korea., Corp |
| 20 Mar 2009 | K090454 | ALLURE MB CERAMIC BRACKETS | Dentsply Interntional |
| 7 Nov 2008 | K082974 | MYSTIQUE MB CERAMIC BRACKETS | Dentsply Interntional |
| 17 Oct 2008 | K080906 | CDB CLIP | Cdb Corporation |
| 24 Sep 2008 | K081415 | DAMON 4CLEAR | Sybron Dental Specialties |
| 4 Aug 2008 | K080749 | RADIANCE | American Orthodontics |
| 18 Dec 2007 | K073045 | SAPPHIRE CERAMIC BRACKET | Ortho Technology, Inc. |
| 18 Oct 2006 | K062305 | CLARITY MODIFIED CERAMIC BRACKETS | 3M Unitek Corporation |
| 10 Apr 2006 | K060837 | IN-OVATION C | Dentsply International, Inc. |
| 23 Sep 2005 | K052245 | ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS | Lar Mfg., LLC |
| 4 Nov 2004 | K042905 | NEO-CLIP ORTHODONTIC BRACKET ACCESSORY | Dentsply Intl., Inc. |
| 30 Aug 2004 | K042178 | ORTHODONTIC CERAMIC BRACKETS | Dentsply Intl., Inc. |
| 3 May 1995 | K950992 | CERAMAFLEX BRACKET SYSTEM | Tp Orthodontics, Inc. |
| 6 Aug 1990 | K902075 | INTRIGUE CERAMIC BRACKET | Lancer Orthodontics, Inc. |
Official records: FDA product classification for NJM · 21 CFR 872.5470.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026