Product Code: NJM
FDA class 2
21 CFR 872.5470
Bracket, Ceramic, Orthodontic
Dental
The Ceramic Orthodontic Bracket is a dental device composed of ceramic material, intended to be bonded to a tooth surface to serve as an anchor through which an orthodontic wire is used to move the tooth to a desired position. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NJM and regulation 21 CFR 872.5470 in the Dental specialty. The device is eligible for third-party review and carries no implant or life-sustaining flags.
510(k)s
60
FEI Numbers
56
Registration Numbers
56
Unique Applicants
45
Years Active
33
Basic Information
- Product Code
- NJM
- Device Class
- FDA class 2
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
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.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 60 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232827 | LightForce Orthodontic System | Sep 14, 2023 | Substantially Equivalent | LightForce Orthodontics |
| K232011 | Cleo | Jul 07, 2023 | Substantially Equivalent | American Orthodontics |
| K231635 | A-Line Advanced | Jun 06, 2023 | Substantially Equivalent | Biocetec Co., Ltd |
| K230225 | DynaFlex Clear Brackets & Buttons | Jun 05, 2023 | Substantially Equivalent | Dyna Flex |
| K222847 | Ceramic Brackets Orthometric | May 04, 2023 | Substantially Equivalent | Orthometric - Industria e Comercio de Produtos Medicos |
| K222764 | LightForce Orthodontic System | Sep 14, 2022 | Substantially Equivalent | LightForce Orthodontics |
| K220689 | Vatech Clismile | May 06, 2022 | Substantially Equivalent | Rayence Co.,Ltd |
| K201410 | VENUS Bracket, ROSE Bracket | Mar 12, 2021 | Substantially Equivalent | GNI Co., LTD |
| K201038 | Luce Ceramic Bracket | Oct 09, 2020 | Substantially Equivalent | Luce Castle Co., Ltd. |
| K200148 | LightForce Orthodontic System (LFO System) | Feb 21, 2020 | Substantially Equivalent | LightForce Orthodontics |
| K182672 | ROSA Bracket | Nov 15, 2019 | Substantially Equivalent | GNI Co., LTD |
| K192202 | Clear21 | Nov 12, 2019 | Substantially Equivalent | World Class Technology Corporation |
| K190608 | Mei Ceramic Bracket | Nov 04, 2019 | Substantially Equivalent | Orthosun Co., Ltd. |
| K180952 | Ceramic Bracket | Jun 07, 2019 | Substantially Equivalent | MEM Dental Technology Co., Ltd |
| K182193 | S-Line | Jan 22, 2019 | Substantially Equivalent | BIO CETEC CO., LTD. |
| K183542 | Signature Orthodontic System | Jan 02, 2019 | Substantially Equivalent | Signature Orthodontics |
| K181271 | Signature Orthodontic System | Jun 13, 2018 | Substantially Equivalent | Signature Orthodontics |
| K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | Mar 16, 2018 | Substantially Equivalent | 3M Health Care |
| K173440 | Carriere SLX 3D Clear | Mar 08, 2018 | Substantially Equivalent | Ortho Organizers, Inc. |
| K172845 | Symetri Clear | Jan 31, 2018 | Substantially Equivalent | Ormco Corporation |
| K171844 | Inspire ICE aka Inspire ICE Clear Brackets | Jul 18, 2017 | Substantially Equivalent | Ormco Corporation |
| K163467 | C-Line Orthodontic Ceramic Bracket | Jun 14, 2017 | Substantially Equivalent | BIOCETEC CO., LTD |
| K163117 | Alpha Pure | May 09, 2017 | Substantially Equivalent | KOROAD AMERICA |
| K160957 | CDB Self Ligating Bracket 8F | Sep 27, 2016 | Substantially Equivalent | CDB CORPORATION |
| K160615 | ORTHODONTIC CERAMIC BRACKETS 1.1 | Aug 26, 2016 | Substantially Equivalent | TOMY, INC |
| K152167 | BIJOU Orthodontic Ceramic Bracket | May 27, 2016 | Substantially Equivalent | WORLD BIO TECH CO., LTD |
| K152779 | Avex CX2 | Nov 25, 2015 | Substantially Equivalent | Opal Orthodontics by Ultradent Products |
| K150141 | Orthodontics Bracket | Oct 23, 2015 | Substantially Equivalent | Speed Dental Co., Ltd. |
| K142729 | Chi Lites Orthodontic Sapphire Bracket | May 15, 2015 | Substantially Equivalent | PROGRESSIVE TECHNOLOGY, INC. |
| K141104 | TRUKLEAR BRACKET | Jun 25, 2014 | Substantially Equivalent | AJW TECHNOLOGY CONSULTANTS, INC. |
| K132368 | VAPOR CERAMIC BRACKET | Dec 19, 2013 | Substantially Equivalent | ORTHODONTIC DESIGN AND PRODUCTION, INC. |
| K131197 | EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS | Aug 27, 2013 | Substantially Equivalent | DENTAL MORELLI |
| K130446 | FASTBRACES CERAMIC BRACKETS | Jun 07, 2013 | Substantially Equivalent | ORTHODONTIC DESIGN AND PRODUCTION, INC. |
| K123092 | CERAMIN BRACKETS Z | Dec 21, 2012 | Substantially Equivalent | TOMY, INC. |
| K122753 | EMPOWER CLEAR | Dec 14, 2012 | Substantially Equivalent | AMERICAN ORTHODONTICS |
| K123094 | ORTHODONTIC CERAMIC BRACKETS | Dec 13, 2012 | Substantially Equivalent | TOMY, INC. |
| K120471 | MACH BRACKETS BRIGHT BRACKETS | Jun 04, 2012 | Substantially Equivalent | WORLD BIO TECH CO., LTD |
| K113334 | AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS | Feb 03, 2012 | Substantially Equivalent | OPAL ORTHODONTICS BY ULTRADENT PRODUCTS INC. |
| K112707 | GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM | Jan 13, 2012 | Substantially Equivalent | ORTHO TECHNOLOGY, INC |
| K110335 | CERAMIC BRACKETS | May 19, 2011 | Substantially Equivalent | ORTHO ORGANIZERS, INC. |
| K111234 | CLICK-IT | May 13, 2011 | Substantially Equivalent | TP ORTHODONTICS, INC. |
| K102803 | CLARITY ADVANCED CERAMIC BRACKETS | Feb 17, 2011 | Substantially Equivalent | 3M UNITEK CORPORATION |
| K102561 | ORTHODONTIC CERAMIC BRACKET | Jan 25, 2011 | Substantially Equivalent | HT CO., LTD. |
| K101481 | BIOMERS TRANSLUCENT ORTHODONTIC BRACKET | Jun 23, 2010 | Substantially Equivalent | BIOMERS PRODUCTS, LLC |
| K091702 | CDB FLIP-SIDE-CLIP BRACKET | Aug 07, 2009 | Substantially Equivalent | CDB CORPORATION |
| K090933 | BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS | Jun 05, 2009 | Substantially Equivalent | FORESTADENT BERNHARD FORSTER GMBH |
| K090567 | ORTHODONTIC CERAMIC BRACKET | May 27, 2009 | Substantially Equivalent | STAR DENTECH KOREA., CORP |
| K090454 | ALLURE MB CERAMIC BRACKETS | Mar 20, 2009 | Substantially Equivalent | DENTSPLY INTERNTIONAL |
| K082974 | MYSTIQUE MB CERAMIC BRACKETS | Nov 07, 2008 | Substantially Equivalent | DENTSPLY INTERNTIONAL |
| K080906 | CDB CLIP | Oct 17, 2008 | Substantially Equivalent | CDB CORPORATION |
| K081415 | DAMON 4CLEAR | Sep 24, 2008 | Substantially Equivalent | ORMCO CORP. |
| K080749 | RADIANCE | Aug 04, 2008 | Substantially Equivalent | AMERICAN ORTHODONTICS |
| K073045 | SAPPHIRE CERAMIC BRACKET | Dec 18, 2007 | Substantially Equivalent | ORTHO TECHNOLOGY, INC |
| K062305 | CLARITY MODIFIED CERAMIC BRACKETS | Oct 18, 2006 | Substantially Equivalent | 3M UNITEK |
| K060837 | IN-OVATION C | Apr 10, 2006 | Substantially Equivalent | DENTSPLY INTERNATIONAL |
| K052245 | ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS | Sep 23, 2005 | Substantially Equivalent | LAR MFG., LLC. |
| K042905 | NEO-CLIP ORTHODONTIC BRACKET ACCESSORY | Nov 04, 2004 | Substantially Equivalent | DENTSPLY INTL. |
| K042178 | ORTHODONTIC CERAMIC BRACKETS | Aug 30, 2004 | Substantially Equivalent | DENTSPLY INTL. |
| K950992 | CERAMAFLEX BRACKET SYSTEM | May 03, 1995 | Substantially Equivalent | TP ORTHODONTICS, INC. |
| K902075 | INTRIGUE CERAMIC BRACKET | Aug 06, 1990 | Substantially Equivalent | LANCER ORTHODONTICS, INC. |
FEI Numbers
This FDA classification entry is associated with 56 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.