Bracket, Ceramic, Orthodontic
Regulation 872.5470
0510(k)s in 12 months (60 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in NJM
| Company | 510(k)s | Recalls |
|---|---|---|
| American Orthodontics | 3 | 0 |
| Biocetec Co., Ltd. | 3 | 0 |
| Cdb Corporation | 3 | 0 |
| Lightforce Orthodontics | 3 | 0 |
| Ormco Corp. | 3 | 0 |
| Tomy, Inc. | 3 | 0 |
| 3M Unitek | 2 | 0 |
| Dentsply Interntional | 2 | 0 |
| Dentsply Intl. | 2 | 0 |
| Gni Co., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2023 | K232827 | LightForce Orthodontic System Lightforce Orthodontics | NJM |
| Jul 7, 2023 | K232011 | Cleo American Orthodontics | NJM |
| Jun 6, 2023 | K231635 | A-Line Advanced Biocetec Co., Ltd., KR | NJM |
| Jun 5, 2023 | K230225 | DynaFlex Clear Brackets & Buttons Dyna Flex | NJM |
| May 4, 2023 | K222847 | Ceramic Brackets Orthometric Orthometric - Industria E Comercio DE Produtos Medicos, BR | NJM |
| Sep 14, 2022 | K222764 | LightForce Orthodontic System Lightforce Orthodontics | NJM |
| May 6, 2022 | K220689 | Vatech Clismile Rayence Co., Ltd., KR | NJM |
| Mar 12, 2021 | K201410 | VENUS Bracket, ROSE Bracket Gni Co., Ltd., KR | NJM |
| Oct 9, 2020 | K201038 | Luce Ceramic Bracket Luce Castle Co., Ltd., KR | NJM |
| Feb 21, 2020 | K200148 | LightForce Orthodontic System (LFO System) Lightforce Orthodontics | NJM |
| Nov 15, 2019 | K182672 | ROSA Bracket Gni Co., Ltd., KR | NJM |
| Nov 12, 2019 | K192202 | Clear21 World Class Technology Corporation | NJM |
| Nov 4, 2019 | K190608 | Mei Ceramic Bracket Orthosun Co., Ltd., KR | NJM |
| Jun 7, 2019 | K180952 | Ceramic Bracket Mem Dental Technology Co., Ltd., TW | NJM |
| Jan 22, 2019 | K182193 | S-Line Biocetec Co., Ltd., KR | NJM |
| Jan 2, 2019 | K183542 | Signature Orthodontic System Signature Orthodontics | NJM |
| Jun 13, 2018 | K181271 | Signature Orthodontic System Signature Orthodontics | NJM |
| Mar 16, 2018 | K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System 3M Healthcare | NJM |
| Mar 8, 2018 | K173440 | Carriere SLX 3D Clear Ortho Organizers, Inc. | NJM |
| Jan 31, 2018 | K172845 | Symetri Clear Ormco Corporation | NJM |
| Jul 18, 2017 | K171844 | Inspire ICE aka Inspire ICE Clear Brackets Ormco Corporation | NJM |
| Jun 14, 2017 | K163467 | C-Line Orthodontic Ceramic Bracket Biocetec Co., Ltd., KR | NJM |
| May 9, 2017 | K163117 | Alpha Pure Koroad America | NJM |
| Sep 27, 2016 | K160957 | CDB Self Ligating Bracket 8F Cdb Corporation | NJM |
| Aug 26, 2016 | K160615 | ORTHODONTIC CERAMIC BRACKETS 1.1 Tomy, Inc., JP | NJM |
| May 27, 2016 | K152167 | BIJOU Orthodontic Ceramic Bracket World Bio Tech Co., Ltd., KR | NJM |
| Nov 25, 2015 | K152779 | Avex CX2 Opal Orthodontics by Ultradent Products | NJM |
| Oct 23, 2015 | K150141 | Orthodontics Bracket Speed Dental Co., Ltd., KR | NJM |
| May 15, 2015 | K142729 | Chi Lites Orthodontic Sapphire Bracket Progressive Technology, Inc. | NJM |
| Jun 25, 2014 | K141104 | TRUKLEAR BRACKET Ajw Technology Consultants, Inc. | NJM |
| Dec 19, 2013 | K132368 | VAPOR CERAMIC BRACKET Orthodontic Design and Production, Inc. | NJM |
| Aug 27, 2013 | K131197 | EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS Dental Morelli | NJM |
| Jun 7, 2013 | K130446 | FASTBRACES CERAMIC BRACKETS Orthodontic Design and Production, Inc. | NJM |
| Dec 21, 2012 | K123092 | CERAMIN BRACKETS Z Tomy, Inc. | NJM |
| Dec 14, 2012 | K122753 | EMPOWER CLEAR American Orthodontics | NJM |
| Dec 13, 2012 | K123094 | ORTHODONTIC CERAMIC BRACKETS Tomy, Inc. | NJM |
| Jun 4, 2012 | K120471 | MACH BRACKETS BRIGHT BRACKETS World Bio Tech Co., Ltd. | NJM |
| Feb 3, 2012 | K113334 | AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS Opal Orthodontics by Ultradent Products, Inc. | NJM |
| Jan 13, 2012 | K112707 | GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM Ortho Technology, Inc. | NJM |
| May 19, 2011 | K110335 | CERAMIC BRACKETS Ortho Organizers, Inc. | NJM |
| May 13, 2011 | K111234 | CLICK-IT Tp Orthodontics, Inc. | NJM |
| Feb 17, 2011 | K102803 | CLARITY ADVANCED CERAMIC BRACKETS 3M Unitek Corporation | NJM |
| Jan 25, 2011 | K102561 | ORTHODONTIC CERAMIC BRACKET Ht Co., Ltd., KR | NJM |
| Jun 23, 2010 | K101481 | BIOMERS TRANSLUCENT ORTHODONTIC BRACKET Biomers Products, LLC | NJM |
| Aug 7, 2009 | K091702 | CDB FLIP-SIDE-CLIP BRACKET Cdb Corporation | NJM |
| Jun 5, 2009 | K090933 | BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS Forestadent Bernhard Forster GmbH, DE | NJM |
| May 27, 2009 | K090567 | ORTHODONTIC CERAMIC BRACKET Star Dentech Korea., Corp | NJM |
| Mar 20, 2009 | K090454 | ALLURE MB CERAMIC BRACKETS Dentsply Interntional | NJM |
| Nov 7, 2008 | K082974 | MYSTIQUE MB CERAMIC BRACKETS Dentsply Interntional | NJM |
| Oct 17, 2008 | K080906 | CDB CLIP Cdb Corporation | NJM |
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