FDA Product Code
FDA Product Code NJM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5470
510(k) Clearances — 60 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232827 | LightForce Orthodontic System | Lightforce Orthodontics | 2023-09-14 | Traditional | PDF ↗ |
| K232011 | Cleo | American Orthodontics | 2023-07-07 | Traditional | PDF ↗ |
| K231635 | A-Line Advanced | Biocetec Co., Ltd. | 2023-06-06 | Traditional | PDF ↗ |
| K230225 | DynaFlex Clear Brackets & Buttons | Dyna Flex | 2023-06-05 | Traditional | PDF ↗ |
| K222847 | Ceramic Brackets Orthometric | Orthometric - Industria E Comercio DE Produtos Medicos | 2023-05-04 | Traditional | PDF ↗ |
| K222764 | LightForce Orthodontic System | Lightforce Orthodontics | 2022-09-14 | Special | PDF ↗ |
| K220689 | Vatech Clismile | Rayence Co., Ltd. | 2022-05-06 | Traditional | PDF ↗ |
| K201410 | VENUS Bracket, ROSE Bracket | Gni Co., Ltd. | 2021-03-12 | Traditional | PDF ↗ |
| K201038 | Luce Ceramic Bracket | Luce Castle Co., Ltd. | 2020-10-09 | Traditional | PDF ↗ |
| K200148 | LightForce Orthodontic System (LFO System) | Lightforce Orthodontics | 2020-02-21 | Traditional | PDF ↗ |
| K182672 | ROSA Bracket | Gni Co., Ltd. | 2019-11-15 | Traditional | PDF ↗ |
| K192202 | Clear21 | World Class Technology Corporation | 2019-11-12 | Traditional | PDF ↗ |
| K190608 | Mei Ceramic Bracket | Orthosun Co., Ltd. | 2019-11-04 | Traditional | PDF ↗ |
| K180952 | Ceramic Bracket | Mem Dental Technology Co., Ltd. | 2019-06-07 | Traditional | PDF ↗ |
| K182193 | S-Line | Biocetec Co., Ltd. | 2019-01-22 | Traditional | PDF ↗ |
| K183542 | Signature Orthodontic System | Signature Orthodontics | 2019-01-02 | Traditional | PDF ↗ |
| K181271 | Signature Orthodontic System | Signature Orthodontics | 2018-06-13 | Traditional | PDF ↗ |
| K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | 3M Healthcare | 2018-03-16 | Traditional | PDF ↗ |
| K173440 | Carriere SLX 3D Clear | Ortho Organizers, Inc. | 2018-03-08 | Traditional | PDF ↗ |
| K172845 | Symetri Clear | Ormco Corporation | 2018-01-31 | Traditional | PDF ↗ |
| K171844 | Inspire ICE aka Inspire ICE Clear Brackets | Ormco Corporation | 2017-07-18 | Traditional | PDF ↗ |
| K163467 | C-Line Orthodontic Ceramic Bracket | Biocetec Co., Ltd. | 2017-06-14 | Traditional | PDF ↗ |
| K163117 | Alpha Pure | Koroad America | 2017-05-09 | Traditional | PDF ↗ |
| K160957 | CDB Self Ligating Bracket 8F | Cdb Corporation | 2016-09-27 | Traditional | PDF ↗ |
| K160615 | ORTHODONTIC CERAMIC BRACKETS 1.1 | Tomy, Inc. | 2016-08-26 | Traditional | PDF ↗ |
| K152167 | BIJOU Orthodontic Ceramic Bracket | World Bio Tech Co., Ltd. | 2016-05-27 | Traditional | PDF ↗ |
| K152779 | Avex CX2 | Opal Orthodontics by Ultradent Products | 2015-11-25 | Special | PDF ↗ |
| K150141 | Orthodontics Bracket | Speed Dental Co., Ltd. | 2015-10-23 | Traditional | PDF ↗ |
| K142729 | Chi Lites Orthodontic Sapphire Bracket | Progressive Technology, Inc. | 2015-05-15 | Traditional | PDF ↗ |
| K141104 | TRUKLEAR BRACKET | Ajw Technology Consultants, Inc. | 2014-06-25 | Special | PDF ↗ |
| K132368 | VAPOR CERAMIC BRACKET | Orthodontic Design and Production, Inc. | 2013-12-19 | Traditional | PDF ↗ |
| K131197 | EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS | Dental Morelli | 2013-08-27 | Traditional | PDF ↗ |
| K130446 | FASTBRACES CERAMIC BRACKETS | Orthodontic Design and Production, Inc. | 2013-06-07 | Traditional | PDF ↗ |
| K123092 | CERAMIN BRACKETS Z | Tomy, Inc. | 2012-12-21 | Traditional | PDF ↗ |
| K122753 | EMPOWER CLEAR | American Orthodontics | 2012-12-14 | Traditional | PDF ↗ |
| K123094 | ORTHODONTIC CERAMIC BRACKETS | Tomy, Inc. | 2012-12-13 | Traditional | PDF ↗ |
| K120471 | MACH BRACKETS BRIGHT BRACKETS | World Bio Tech Co., Ltd. | 2012-06-04 | Traditional | PDF ↗ |
| K113334 | AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS | Opal Orthodontics by Ultradent Products, Inc. | 2012-02-03 | Traditional | PDF ↗ |
| K112707 | GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM | Ortho Technology, Inc. | 2012-01-13 | Traditional | PDF ↗ |
| K110335 | CERAMIC BRACKETS | Ortho Organizers, Inc. | 2011-05-19 | Traditional | PDF ↗ |
| K111234 | CLICK-IT | Tp Orthodontics, Inc. | 2011-05-13 | Traditional | PDF ↗ |
| K102803 | CLARITY ADVANCED CERAMIC BRACKETS | 3M Unitek Corporation | 2011-02-17 | Traditional | PDF ↗ |
| K102561 | ORTHODONTIC CERAMIC BRACKET | Ht Co., Ltd. | 2011-01-25 | Traditional | PDF ↗ |
| K101481 | BIOMERS TRANSLUCENT ORTHODONTIC BRACKET | Biomers Products, LLC | 2010-06-23 | Traditional | PDF ↗ |
| K091702 | CDB FLIP-SIDE-CLIP BRACKET | Cdb Corporation | 2009-08-07 | Traditional | PDF ↗ |
| K090933 | BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS | Forestadent Bernhard Forster GmbH | 2009-06-05 | Traditional | PDF ↗ |
| K090567 | ORTHODONTIC CERAMIC BRACKET | Star Dentech Korea., Corp | 2009-05-27 | Traditional | PDF ↗ |
| K090454 | ALLURE MB CERAMIC BRACKETS | Dentsply Interntional | 2009-03-20 | Special | PDF ↗ |
| K082974 | MYSTIQUE MB CERAMIC BRACKETS | Dentsply Interntional | 2008-11-07 | Special | PDF ↗ |
| K080906 | CDB CLIP | Cdb Corporation | 2008-10-17 | Traditional | PDF ↗ |
| K081415 | DAMON 4CLEAR | Ormco Corp. | 2008-09-24 | Traditional | PDF ↗ |
| K080749 | RADIANCE | American Orthodontics | 2008-08-04 | Traditional | PDF ↗ |
| K073045 | SAPPHIRE CERAMIC BRACKET | Ortho Technology, Inc. | 2007-12-18 | Traditional | PDF ↗ |
| K062305 | CLARITY MODIFIED CERAMIC BRACKETS | 3M Unitek | 2006-10-18 | Traditional | PDF ↗ |
| K060837 | IN-OVATION C | Dentsply International | 2006-04-10 | Special | PDF ↗ |
| K052245 | ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS | Lar Mfg., LLC | 2005-09-23 | Traditional | PDF ↗ |
| K042905 | NEO-CLIP ORTHODONTIC BRACKET ACCESSORY | Dentsply Intl. | 2004-11-04 | Special | PDF ↗ |
| K042178 | ORTHODONTIC CERAMIC BRACKETS | Dentsply Intl. | 2004-08-30 | Special | PDF ↗ |
| K950992 | CERAMAFLEX BRACKET SYSTEM | Tp Orthodontics, Inc. | 1995-05-03 | Traditional | PDF ↗ |
| K902075 | INTRIGUE CERAMIC BRACKET | Lancer Orthodontics, Inc. | 1990-08-06 | Traditional | PDF ↗ |
Product code NJM · Class II · Dental. Data: openFDA.