FDA Product Code
FDA Product Code NXC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5470
510(k) Clearances — 145 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182388 | Krystal Klear Aligners | Shatkin F.I.R.S.T., LLC | 2019-12-19 | Traditional | PDF ↗ |
| K190394 | SunClear Aligner system | Sun Dental Laboratories, LLC | 2019-12-16 | Traditional | PDF ↗ |
| K190003 | Vivid Aligners | Orthodent Laboratory, Inc. | 2019-11-06 | Traditional | PDF ↗ |
| K191774 | SmileAlign Orthodontic Aligner System | 3D Global Biotech, Inc. | 2019-09-30 | Traditional | PDF ↗ |
| K192119 | 3M Clarity Aligners | 3M Company | 2019-09-05 | Traditional | PDF ↗ |
| K191990 | OSW Aligner System | Osw Manufacturing, LLC | 2019-08-23 | Traditional | PDF ↗ |
| K190583 | DynaFlex | Dyna Flex | 2019-06-27 | Traditional | PDF ↗ |
| K182658 | Bioliner | Five Star Orthodontic Lab & Supply | 2019-06-19 | Traditional | PDF ↗ |
| K183229 | Argen Clear Aligner | Argen Corporation | 2019-06-07 | Traditional | PDF ↗ |
| K190948 | Magic Clear Aligners | Voodoo Manufacturing, Inc. | 2019-05-09 | Traditional | PDF ↗ |
| K181747 | Orthodontic Appliance | Shandong Huge Dental Material Corporation | 2019-04-18 | Traditional | PDF ↗ |
| K180346 | Byte Aligner System | Straight Smile, LLC | 2019-02-19 | Traditional | PDF ↗ |
| K180648 | Park Dental Research Aligners | Park Dental Research Corporation | 2019-01-08 | Traditional | PDF ↗ |
| K183643 | Clear Image Aligners | Specialty Appliance Works, Inc. | 2019-01-03 | Traditional | PDF ↗ |
| K183159 | 3M Clarity Aligners | 3M Company | 2018-11-26 | Traditional | PDF ↗ |
| K182329 | SureCure Orthodontic Aligner System | Digital Orthodontic Care | 2018-11-08 | Traditional | PDF ↗ |
| K181739 | Invisalign System with Mandibular Advancement Feature | Align Technology, Inc. | 2018-10-26 | Traditional | PDF ↗ |
| K182826 | Ormco Spark Aligner System | Sybron Dental Specialties | 2018-10-11 | Traditional | PDF ↗ |
| K180241 | Orthocaps Twinaligner | Ortho Caps GmbH | 2018-09-28 | Traditional | PDF ↗ |
| K173784 | Smylic Invisible Clear Aligners | Smylio, Inc. | 2018-08-23 | Traditional | PDF ↗ |
| K172765 | Smart Moves Complete | Great Lakes Orthodontics, Ltd. | 2018-06-01 | Traditional | PDF ↗ |
| K173785 | Custom Clear Aligner System | Derby Dental Laboratory | 2018-03-13 | Traditional | PDF ↗ |
| K180107 | Blue Sky Bio Aligner | Blue Sky Bio, LLC | 2018-02-09 | Traditional | PDF ↗ |
| K171674 | Angel Align System | Smile Development Corp | 2018-01-19 | Traditional | PDF ↗ |
| K171860 | Sureclear aligners | Emergo Global Consulting, LLC | 2018-01-05 | Traditional | PDF ↗ |
| K162609 | ClearPath Aligner | Clearpath Orthodontics, Ltd. | 2017-07-06 | Traditional | PDF ↗ |
| K163155 | MTM Clear Aligner | Dentsply Sirona | 2017-02-03 | Traditional | PDF ↗ |
| K163689 | 3M Clear Tray Aligner | 3M Unitek Corporation | 2017-01-27 | Traditional | PDF ↗ |
| K151965 | Dentti System | Martz, Inc. | 2016-03-11 | Traditional | PDF ↗ |
| K143630 | Invisalign System | Align Technology, Inc. | 2015-11-18 | Traditional | PDF ↗ |
| K143499 | eCligner | Eclear International Co., Ltd. | 2015-10-09 | Traditional | PDF ↗ |
| K123514 | CLEARPATH ALIGNER | Qserve America, Inc. | 2013-11-01 | Traditional | PDF ↗ |
| K132145 | MTM(R) CLEAR ALIGNER | Dentsply International, Inc. | 2013-10-11 | Traditional | PDF ↗ |
| K123925 | MTM CLEAR ALIGNER IN-OFFICE | Dentsply International, Inc. | 2013-05-24 | Traditional | PDF ↗ |
| K130237 | PONTIC PAINT | Reliance Orthodontic Products, Inc. | 2013-04-05 | Traditional | PDF ↗ |
| K121396 | DYNAFLEX | Dyna Flex | 2012-08-14 | Traditional | PDF ↗ |
| K113618 | CLEARCORRECT SYSTEM | Clearcorrect, Inc. | 2012-03-19 | Traditional | PDF ↗ |
| K093821 | FS ALIGNER | Allesee Orthodontic Appliances | 2010-08-27 | Traditional | PDF ↗ |
| K073121 | NUBRACE INVISIBLE REMOVABLE ORTHODONTICS | Nubrace, Inc. | 2009-02-12 | Traditional | PDF ↗ |
| K082556 | CLEARCORRECT | Clearcorrect, Inc. | 2009-02-06 | Traditional | PDF ↗ |
| K081960 | INVISALIGN SYSTEM | Align Technology | 2008-12-17 | Traditional | PDF ↗ |
| K080246 | COMPOSITE ALIGNER BUTTON | Dentsply Interntional | 2008-04-11 | Traditional | PDF ↗ |
| K071970 | CLEAR IMAGE ALIGNER | Specialty Appliance Works, Inc. | 2007-09-25 | Traditional | PDF ↗ |
| K040874 | RED, WHITE & BLUE | Allesee Orthodontic Appliances | 2004-06-18 | Traditional | PDF ↗ |
| K981095 | ALIGN SYSTEM | Align Technology | 1998-09-08 | Traditional | PDF ↗ |
Product code NXC · Class II · Dental. Data: openFDA.