FDA 510(k) Applications for Medical Device Product Code "NXC"
(Aligner, Sequential)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K200908 | 3D Diagnostix Inc. | iSMILE | 12/22/2020 |
| K212803 | 3D Global Biotech Inc | DailyMate Orthodontic Aligner System | 05/23/2022 |
| K191774 | 3D Global Biotech Inc. | SmileAlign Orthodontic Aligner System | 09/30/2019 |
| K200214 | 3D Smile USA, Inc | 3D Predict | 02/24/2020 |
| K183159 | 3M Company | 3M Clarity Aligners | 11/26/2018 |
| K192119 | 3M Company | 3M Clarity Aligners | 09/05/2019 |
| K211190 | 3M Company, Unitek Orthodontic Products | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) | 04/23/2021 |
| K231464 | 3M Company, Unitek Orthodontic Products | 3MÖ ClarityÖ Aligners (3MÖ ClarityÖ Aligners-Force, 3MÖ ClarityÖ Aligners-Flex) | 05/22/2023 |
| K233257 | 3M Company, Unitek Orthodontic Products | 3MÖ ClarityÖAligners with Quick Attachments | 09/29/2023 |
| K163689 | 3M Unitek Corporation | 3M Clear Tray Aligner | 01/27/2017 |
| K241187 | Alien Milling Technologies | Alien Aligners | 07/26/2024 |
| K981095 | ALIGN TECHNOLOGY | ALIGN SYSTEM | 09/08/1998 |
| K081960 | ALIGN TECHNOLOGY | INVISALIGN SYSTEM | 12/17/2008 |
| K232887 | Align Technology, Inc. | Invisalign Palatal Expander System | 12/15/2023 |
| K143630 | ALIGN TECHNOLOGY, INC. | Invisalign System | 11/18/2015 |
| K220287 | Align Technology, Inc. | Invisalign System | 04/07/2022 |
| K241412 | Align Technology, Inc. | Invisalign System | 06/18/2024 |
| K181739 | Align Technology, Inc. | Invisalign System with Mandibular Advancement Feature | 10/26/2018 |
| K232233 | Align Technology, Inc. | Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | 09/26/2023 |
| K222894 | Align Technology, Inc. | Invisalign System, Pre-Formed Attachment System | 12/22/2022 |
| K093821 | ALLESEE ORTHODONTIC APPLIANCES | FS ALIGNER | 08/27/2010 |
| K040874 | ALLESEE ORTHODONTIC APPLIANCES | RED, WHITE & BLUE | 06/18/2004 |
| K192244 | ArcadLab | Arcad SmileStudio and Aligner System | 05/11/2020 |
| K183229 | Argen Corporation | Argen Clear Aligner | 06/07/2019 |
| K192846 | Argen Corporation | Argen Clear Aligner, Argen Clear Aligner Premium | 02/10/2020 |
| K220835 | Arklign Laboratories | Arkligners | 08/12/2022 |
| K201104 | Aso International Manila, Inc. | AsoAligner | 02/26/2021 |
| K212961 | Biotech Dental Smilers, SAS | SMILERS | 09/20/2021 |
| K180107 | Blue Sky Bio LLC | Blue Sky Bio Aligner | 02/09/2018 |
| K221845 | Blue Sky Bio, LLC | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G | 02/24/2023 |
| K232653 | Blue Sky Bio, LLC | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | 04/03/2024 |
| K202792 | Brius Technologies, Inc | BRIUS Clear Aligners | 01/22/2021 |
| K191823 | CDB Corporation | Clear-Aligners | 12/20/2019 |
| K210613 | CDB Corporation | HIT Clear Aligner | 06/04/2021 |
| K241137 | Clear Moves Aligners | Clear Moves Aligner | 08/01/2024 |
| K210320 | ClearCorrect LLC | ClearCorrect System | 08/06/2021 |
| K082556 | CLEARCORRECT, INC. | CLEARCORRECT | 02/06/2009 |
| K113618 | CLEARCORRECT, INC. | CLEARCORRECT SYSTEM | 03/19/2012 |
| K220140 | ClearCorrect, LLC | ClearCorrect System | 10/05/2022 |
| K162609 | ClearPath Orthodontics Ltd | ClearPath Aligner | 07/06/2017 |
| K202857 | ClearPath Orthodontics Ltd | ClearPath Aligner | 01/05/2021 |
| K211427 | CreoDent Prosthetics LTD | CREOKORREKT Aligners | 10/13/2022 |
| K242892 | Cristaline Aligners GmbH | Cristaline Aligners Z FLX | 12/19/2024 |
| K192470 | DenMat Holdings, LLC | DenMat Orthodontic Aligners | 12/20/2019 |
| K222918 | DentCare Dental Lab Pvt Ltd. | DentCare Aligners | 11/25/2022 |
| K233544 | Dentis Co., Ltd | MESHEET | 02/22/2024 |
| K123925 | DENTSPLY INTERNATIONAL, INC. | MTM CLEAR ALIGNER IN-OFFICE | 05/24/2013 |
| K132145 | DENTSPLY INTERNATIONAL, INC. | MTM(R) CLEAR ALIGNER | 10/11/2013 |
| K080246 | DENTSPLY INTERNTIONAL | COMPOSITE ALIGNER BUTTON | 04/11/2008 |
| K163155 | DENTSPLY SIRONA | MTM Clear Aligner | 02/03/2017 |
| K230199 | Dentsply Sirona Inc. | Byte Aligner System | 10/18/2023 |
| K173785 | Derby Dental Laboratory | Custom Clear Aligner System | 03/13/2018 |
| K182329 | Digital Orthodontic Care | SureCure Orthodontic Aligner System | 11/08/2018 |
| K200005 | Drake Precision Dental Laboratory Inc | Concinnity Aligners | 11/09/2020 |
| K192069 | Dror Orthodesign | Aerodentis System | 05/06/2020 |
| K121396 | DYNA FLEX | DYNAFLEX | 08/14/2012 |
| K190583 | DynaFlex | DynaFlex | 06/27/2019 |
| K143499 | eClear International Co., Ltd. | eCligner | 10/09/2015 |
| K171860 | Emergo Global Consulting, LLC | Sureclear aligners | 01/05/2018 |
| K222619 | Ensmile Pvt Ltd | Ensmile | 03/16/2023 |
| K202685 | Eon Dental Jordan LLC | Eon Aligner | 09/28/2020 |
| K182658 | Five Star Orthodontic Lab & Supply | Bioliner | 06/19/2019 |
| K233152 | Geniova Technologies Sociedad Limitada | GENIOVA aligners | 12/12/2024 |
| K240597 | Graphy Inc. | TERA HARZ CLEAR | 03/05/2024 |
| K223355 | Graphy Inc. | Tera Harz Clear | 11/03/2022 |
| K172765 | Great Lakes Orthodontics Ltd | Smart Moves Complete | 06/01/2018 |
| K222418 | Gruppo Europeo Ortodonzia srl | Nuvola | 10/07/2022 |
| K210763 | Inman Orthodontic Laboratories, Inc. | Inman Digital Clear Aligners | 09/29/2021 |
| K213297 | Johns Dental Laboratories | Redline | 02/09/2022 |
| K220726 | K Line Europe GmbH | K Clear | 03/16/2022 |
| K221475 | Key Dental Technologies, LLC | MyClearALIGN Dental Aligner System | 08/31/2022 |
| K233356 | Laxmi Dental Export PVT. LTD | Illusion Aligner Pro: Illusion Aligner FLX | 08/08/2024 |
| K211010 | Laxmi Dental Exports Pvt Ltd | Illusion Aligners | 04/26/2021 |
| K212680 | Luxcreo Inc | LuxCreo Clear Aligner System | 05/31/2022 |
| K250343 | LuxCreo Inc. | LuxCreo Clear Aligner System | 04/08/2025 |
| K223338 | Makeo Healthcare Technologies Private Limited | Toothsi, Smilealigners | 02/09/2023 |
| K151965 | Martz, Inc | Dentti System | 03/11/2016 |
| K242637 | MEM Dental Technology Co., Ltd. | MEM Clear Aligner System | 05/21/2025 |
| K231884 | Modern Dental Laboratory (DG) Co., Ltd. | TRIOCLEAR System | 09/01/2023 |
| K191838 | Motor City Lab Works | Clearform Aligners | 03/20/2020 |
| K193130 | MVP Aligners, LLC | MVP Aligner System | 08/07/2020 |
| K222308 | Nanjing Jiahe Dental Technology Co., Ltd. | Al Smile Aligner | 12/20/2022 |
| K203339 | New England Ortho Lab, Inc | NEOLab Clear Aligners | 01/06/2021 |
| K192338 | New England Ortho Lab, Inc. | NEOLab Clear Aligners | 03/12/2020 |
| K073121 | NUBRACE, INC. | NUBRACE INVISIBLE REMOVABLE ORTHODONTICS | 02/12/2009 |
| K251616 | ODS Co., Ltd. | Clear Miracle | 07/22/2025 |
| K210540 | Ohlendorf Appliance Laboratory | Ohlendorf Clear Aligner | 05/19/2021 |
| K211537 | Oral Image, Inc | QuickAligners | 10/26/2021 |
| K221097 | Ordont Orthodontic Laboratories, Inc. | SmileSeries | 07/14/2022 |
| K203737 | Ormco Corporation | Spark Clear Aligner System | 03/22/2021 |
| K240501 | Ormco Corporation | SparkÖ Clear Aligner System | 10/11/2024 |
| K250487 | Ormco Corporation | SparkTM Clear Aligner System | 02/20/2025 |
| K180241 | Ortho Caps GmbH | Orthocaps Twinaligner | 09/28/2018 |
| K212496 | Ortho Lab Services, LLC | Ortho Aligner System | 11/04/2021 |
| K190003 | Orthodent Laboratory, Inc. | Vivid Aligners | 11/06/2019 |
| K191990 | OSW Manufacturing, LLC | OSW Aligner System | 08/23/2019 |
| K233935 | Park Dental Research Corporation | DigiLine Direct Print Aligner System | 04/05/2024 |
| K180648 | Park Dental Research Corporation | Park Dental Research Aligners | 01/08/2019 |
| K242715 | Pearl Digital Inc. | Pearl Clear Aligner | 01/16/2025 |
| K193622 | Perfection Aligner System Hong Kong Limited | TRIOCLEAR System | 07/06/2021 |
| K212772 | Precision Align LLC. | Precision Align | 01/15/2022 |
| K123514 | QSERVE AMERICA, INC. | CLEARPATH ALIGNER | 11/01/2013 |
| K130237 | RELIANCE ORTHODONTIC PRODUCTS, INC. | PONTIC PAINT | 04/05/2013 |
| K192767 | Royal Dental Lab | Clear Aligner | 01/08/2020 |
| K181747 | Shandong Huge Dental Material Corporation | Orthodontic Appliance | 04/18/2019 |
| K182388 | Shatkin F.I.R.S.T. LLC | Krystal Klear Aligners | 12/19/2019 |
| K213026 | Shenzhen Meiming Dentistry Technology Co., Ltd | Clear Aligner | 08/16/2022 |
| K210373 | Shenzhen Yinuo Dental Technology Co.LTD | Clear Aligners | 08/27/2021 |
| K171674 | Smile Development Corp | Angel Align System | 01/19/2018 |
| K210652 | SMS OPCO, LLC | 6MS Invisible Aligner | 06/02/2021 |
| K221537 | Smylio Inc. | Nightwear Aligners | 04/05/2023 |
| K173784 | Smylio, Inc | Smylic Invisible Clear Aligners | 08/23/2018 |
| K212660 | Smylio, Inc | Smylio Invisible Clear Aligners | 09/22/2021 |
| K240038 | Space Maintainers Laboratories (SML) | Clear Moves Aligners | 04/04/2024 |
| K071970 | SPECIALTY APPLIANCE WORKS, INC. | CLEAR IMAGE ALIGNER | 09/25/2007 |
| K183643 | Specialty Appliance Works, Inc. | Clear Image Aligners | 01/03/2019 |
| K223141 | STR8 Oral Care | STR8 Clear Aligner | 04/24/2023 |
| K180346 | Straight Smile, LLC | Byte Aligner System | 02/19/2019 |
| K201450 | Straight T, Inc. | Straight T Clear Dental Aligner | 09/10/2020 |
| K190394 | Sun Dental Laboratories, LLC | SunClear Aligner system | 12/16/2019 |
| K182826 | Sybron Dental Specialties | Ormco Spark Aligner System | 10/11/2018 |
| K232074 | TNS Co., Ltd. | Serafin« | 02/22/2024 |
| K193385 | TP Orthodontics Inc. | TP Orthodontics Clear Aligner System | 11/12/2020 |
| K211510 | uLab Systems, Inc. | uLab Systems Dental Aligner Kit | 02/24/2022 |
| K192596 | uLab Systems, Inc. | ULab Systems Dental Aligner Kit | 02/11/2020 |
| K191308 | Universal Orthodontic Laboratory Inc | U-Aligner | 04/23/2020 |
| K173738 | Utah Medical Products and Services | Archworx | 02/26/2021 |
| K191837 | Vitang Technology, LLC | UniSmile Clear Aligner System | 01/29/2020 |
| K190948 | Voodoo Manufacturing, Inc. | Magic Clear Aligners | 05/09/2019 |
| K203688 | Wuxi EA Medical Instruments Technologies Limited. | Clear Aligner | 10/08/2021 |
| K223517 | Wuxi EA Medical Instruments Technologies Limited. | Clear Aligner | 06/13/2023 |
| K242929 | Xplora 3D Europe S.L | Fas Aligner System | 12/20/2024 |
| K203624 | Zhejiang Yinchili Medical Technology Co., Ltd. | Custom-made Invisible Aligners | 06/16/2022 |
| K223454 | Zhejiang Yinchili Medical Technology Co., Ltd. | Custom-made Invisible Aligners | 04/17/2023 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
