NJM · Bracket, Ceramic, Orthodontic
Dental · 21 CFR 872.5470 · Class 2
Overview
| Product Code | NJM |
|---|---|
| Device Name | Bracket, Ceramic, Orthodontic |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.
Classification Rationale
Class II.
Cleared Devices (60)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232827 | LightForce Orthodontic System | Lightforce Orthodontics | Sep 14, 2023 | SESE |
| K232011 | Cleo | American Orthodontics | Jul 7, 2023 | SESE |
| K231635 | A-Line Advanced | Biocetec Co., Ltd. | Jun 6, 2023 | SESE |
| K230225 | DynaFlex Clear Brackets & Buttons | Dyna Flex | Jun 5, 2023 | SESE |
| K222847 | Ceramic Brackets Orthometric | Orthometric - Industria E Comercio DE Produtos Medicos | May 4, 2023 | SESE |
| K222764 | LightForce Orthodontic System | Lightforce Orthodontics | Sep 14, 2022 | SESE |
| K220689 | Vatech Clismile | Rayence Co., Ltd. | May 6, 2022 | SESE |
| K201410 | VENUS Bracket, ROSE Bracket | Gni Co., Ltd. | Mar 12, 2021 | SESE |
| K201038 | Luce Ceramic Bracket | Luce Castle Co., Ltd. | Oct 9, 2020 | SESE |
| K200148 | LightForce Orthodontic System (LFO System) | Lightforce Orthodontics | Feb 21, 2020 | SESE |
| K182672 | ROSA Bracket | Gni Co., Ltd. | Nov 15, 2019 | SESE |
| K192202 | Clear21 | World Class Technology Corporation | Nov 12, 2019 | SESE |
| K190608 | Mei Ceramic Bracket | Orthosun Co., Ltd. | Nov 4, 2019 | SESE |
| K180952 | Ceramic Bracket | Mem Dental Technology Co., Ltd. | Jun 7, 2019 | SESE |
| K182193 | S-Line | Biocetec Co., Ltd. | Jan 22, 2019 | SESE |
| K183542 | Signature Orthodontic System | Signature Orthodontics | Jan 2, 2019 | SESE |
| K181271 | Signature Orthodontic System | Signature Orthodontics | Jun 13, 2018 | SESE |
| K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | 3M Healthcare | Mar 16, 2018 | SESE |
| K173440 | Carriere SLX 3D Clear | Ortho Organizers, Inc. | Mar 8, 2018 | SESE |
| K172845 | Symetri Clear | Ormco Corporation | Jan 31, 2018 | SESE |
| K171844 | Inspire ICE aka Inspire ICE Clear Brackets | Ormco Corporation | Jul 18, 2017 | SESE |
| K163467 | C-Line Orthodontic Ceramic Bracket | Biocetec Co., Ltd. | Jun 14, 2017 | SESE |
| K163117 | Alpha Pure | Koroad America | May 9, 2017 | SESE |
| K160957 | CDB Self Ligating Bracket 8F | Cdb Corporation | Sep 27, 2016 | SESE |
| K160615 | ORTHODONTIC CERAMIC BRACKETS 1.1 | Tomy, Inc. | Aug 26, 2016 | SESE |
| K152167 | BIJOU Orthodontic Ceramic Bracket | World Bio Tech Co., Ltd. | May 27, 2016 | SESE |
| K152779 | Avex CX2 | Opal Orthodontics by Ultradent Products | Nov 25, 2015 | SESE |
| K150141 | Orthodontics Bracket | Speed Dental Co., Ltd. | Oct 23, 2015 | SESE |
| K142729 | Chi Lites Orthodontic Sapphire Bracket | Progressive Technology, Inc. | May 15, 2015 | SESE |
| K141104 | TRUKLEAR BRACKET | Ajw Technology Consultants, Inc. | Jun 25, 2014 | SESE |
| K132368 | VAPOR CERAMIC BRACKET | Orthodontic Design and Production, Inc. | Dec 19, 2013 | SESE |
| K131197 | EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS | Dental Morelli | Aug 27, 2013 | SESE |
| K130446 | FASTBRACES CERAMIC BRACKETS | Orthodontic Design and Production, Inc. | Jun 7, 2013 | SESE |
| K123092 | CERAMIN BRACKETS Z | Tomy, Inc. | Dec 21, 2012 | SESE |
| K122753 | EMPOWER CLEAR | American Orthodontics | Dec 14, 2012 | SESE |
| K123094 | ORTHODONTIC CERAMIC BRACKETS | Tomy, Inc. | Dec 13, 2012 | SESE |
| K120471 | MACH BRACKETS BRIGHT BRACKETS | World Bio Tech Co., Ltd. | Jun 4, 2012 | SESE |
| K113334 | AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS | Opal Orthodontics by Ultradent Products, Inc. | Feb 3, 2012 | SESE |
| K112707 | GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM | Ortho Technology, Inc. | Jan 13, 2012 | SESE |
| K110335 | CERAMIC BRACKETS | Ortho Organizers, Inc. | May 19, 2011 | SESE |
| K111234 | CLICK-IT | Tp Orthodontics, Inc. | May 13, 2011 | SESE |
| K102803 | CLARITY ADVANCED CERAMIC BRACKETS | 3M Unitek Corporation | Feb 17, 2011 | SESE |
| K102561 | ORTHODONTIC CERAMIC BRACKET | Ht Co., Ltd. | Jan 25, 2011 | SESE |
| K101481 | BIOMERS TRANSLUCENT ORTHODONTIC BRACKET | Biomers Products, LLC | Jun 23, 2010 | SESE |
| K091702 | CDB FLIP-SIDE-CLIP BRACKET | Cdb Corporation | Aug 7, 2009 | SESE |
| K090933 | BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS | Forestadent Bernhard Forster GmbH | Jun 5, 2009 | SESE |
| K090567 | ORTHODONTIC CERAMIC BRACKET | Star Dentech Korea., Corp | May 27, 2009 | SESE |
| K090454 | ALLURE MB CERAMIC BRACKETS | Dentsply Interntional | Mar 20, 2009 | SESE |
| K082974 | MYSTIQUE MB CERAMIC BRACKETS | Dentsply Interntional | Nov 7, 2008 | SESE |
| K080906 | CDB CLIP | Cdb Corporation | Oct 17, 2008 | SESE |
| K081415 | DAMON 4CLEAR | Ormco Corp. | Sep 24, 2008 | SESE |
| K080749 | RADIANCE | American Orthodontics | Aug 4, 2008 | SESE |
| K073045 | SAPPHIRE CERAMIC BRACKET | Ortho Technology, Inc. | Dec 18, 2007 | SESE |
| K062305 | CLARITY MODIFIED CERAMIC BRACKETS | 3M Unitek | Oct 18, 2006 | SESE |
| K060837 | IN-OVATION C | Dentsply International | Apr 10, 2006 | SESE |
| K052245 | ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS | Lar Mfg., LLC | Sep 23, 2005 | SESE |
| K042905 | NEO-CLIP ORTHODONTIC BRACKET ACCESSORY | Dentsply Intl. | Nov 4, 2004 | SESE |
| K042178 | ORTHODONTIC CERAMIC BRACKETS | Dentsply Intl. | Aug 30, 2004 | SESE |
| K950992 | CERAMAFLEX BRACKET SYSTEM | Tp Orthodontics, Inc. | May 3, 1995 | SESE |
| K902075 | INTRIGUE CERAMIC BRACKET | Lancer Orthodontics, Inc. | Aug 6, 1990 | SESE |
Top Applicants
- Tomy, Inc. — 3 clearances
- Lightforce Orthodontics — 3 clearances
- Cdb Corporation — 3 clearances
- Biocetec Co., Ltd. — 3 clearances
- American Orthodontics — 3 clearances
