Aligner, Sequential
FDA product code NXC · Class II (moderate risk) · 21 CFR 872.5470 · Dental
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
145510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Align Technology, Inc. 12
- Smylio, Inc. 4
- Clearcorrect, Inc. 4
- 3M Company, Unitek Orthodontic Products 3
- Blue Sky Bio, LLC 3
- Dentsply Sirona 3
- Ormco Corp. 3
- New England Ortho Lab, Inc. 2
- Dentsply International, Inc. 2
- 3D Global Biotech, Inc. 2
- Dyna Flex 2
- Dror Orthodesign , Ltd. 2
- Cdb Corporation 2
- Clearpath Orthodontics, Ltd. 2
- The Argen Corporation 2
- Ulab Systems, Inc. 2
- Specialty Appliance Works, Inc. 2
- Park Dental Research Corp. 2
- 3M Company 2
- Allesee Orthodontic Appliances 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260527 | FACE4D AlignerNXC · Traditional | Avinent Implant System S.L.U. | 07/02/2026SE |
| K260788 | Smylio AlignersNXC · Traditional | Smylio, Inc. | 05/08/2026SE |
| K260722 | SureSmile Aligner (ASSY500020)NXC · Traditional | Dentsply Sirona, Inc. | 04/15/2026SE |
| K253282 | ZSmile SystemNXC · Special | Dror Orthodesign , Ltd. | 02/03/2026SE |
| K251454 | Clear Aligner (SCF-3348)NXC · Traditional | Beame Medical Technology (Shenzhen) Limited | 01/07/2026SE |
| K250739 | Primeprint Direct AlignerNXC · Traditional | Dreve Dentamid GmbH | 11/07/2025SE |
| K252931 | Invisalign® Palatal Expander SystemNXC · Special | Align Technology, Inc. | 10/23/2025SE |
| K252870 | Invisalign Specifix Attachment SystemNXC · Special | Align Technology, Inc. | 10/09/2025SE |
| K251758 | Serafin®NXC · Traditional | Tns Co., Ltd. | 09/11/2025SE |
| K252380 | Invisalign SystemNXC · Special | Align Technology, Inc. | 08/29/2025SE |
| K251415 | Additively Manufactured Aligner ResinNXC · Traditional | Aidite (Qinhuangdao) Technology Co., Ltd. | 08/27/2025SE |
| K251616 | Clear MiracleNXC · Traditional | Ods Co., Ltd. | 07/22/2025SE |
| K242637 | MEM Clear Aligner SystemNXC · Traditional | Mem Dental Technology Co., Ltd. | 05/21/2025SE |
| K250343 | LuxCreo Clear Aligner SystemNXC · Special | LuxCreo, Inc. | 04/08/2025SE |
| K250487 | SparkTM Clear Aligner SystemNXC · Traditional | Ormco Corporation | 02/20/2025SE |
| K242715 | Pearl Clear AlignerNXC · Traditional | Pearl Digital, Inc. | 01/16/2025SE |
| K242929 | Fas Aligner SystemNXC · Traditional | Xplora 3D Europe S.L | 12/20/2024SE |
| K242892 | Cristaline Aligners Z FLXNXC · Traditional | Cristaline Aligners GmbH | 12/19/2024SE |
| K233152 | GENIOVA alignersNXC · Traditional | Geniova Technologies Sociedad Limitada | 12/12/2024SE |
| K240501 | Spark Clear Aligner SystemNXC · Traditional | Ormco Corporation | 10/11/2024SE |
| K233356 | Illusion Aligner Pro: Illusion Aligner FLXNXC · Traditional | Laxmi Dental Export Pvt., Ltd. | 08/08/2024SE |
| K241137 | Clear Moves AlignerNXC · Traditional | Clear Moves Aligners | 08/01/2024SE |
| K241187 | Alien AlignersNXC · Traditional | Alien Milling Technologies | 07/26/2024SE |
| K241412 | Invisalign SystemNXC · Special | Align Technology, Inc. | 06/18/2024SE |
| K233935 | DigiLine Direct Print Aligner SystemNXC · Traditional | Park Dental Research Corporation | 04/05/2024SE |
| K240038 | Clear Moves AlignersNXC · Traditional | Space Maintainers Laboratories (Sml) | 04/04/2024SE |
| K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXNXC · Traditional | Blue Sky Bio, LLC | 04/03/2024SE |
| K240597 | Tera Harz ClearNXC · Special | Graphy, Inc. | 03/05/2024SE |
| K233544 | MesheetNXC · Traditional | Dentis Co., Ltd. | 02/22/2024SE |
| K232074 | Serafin®NXC · Traditional | Tns Co., Ltd. | 02/22/2024SE |
| K232887 | Invisalign Palatal Expander SystemNXC · Traditional | Align Technology, Inc. | 12/15/2023SE |
| K230199 | Byte Aligner SystemNXC · Traditional | Dentsply Sirona, Inc. | 10/18/2023SE |
| K233257 | 3M ClarityAligners with Quick AttachmentsNXC · Traditional | 3M Company, Unitek Orthodontic Products | 09/29/2023SE |
| K232233 | Invisalign System with Mandibular Advancement Featuring Occlusal BlocksNXC · Traditional | Align Technology, Inc. | 09/26/2023SE |
| K231884 | TRIOCLEAR SystemNXC · Special | Modern Dental Laboratory (Dg) Co., Ltd. | 09/01/2023SE |
| K223517 | Clear AlignerNXC · Traditional | Wuxi EA Medical Instruments Technologies Limited. | 06/13/2023SE |
| K231464 | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)NXC · Traditional | 3M Company, Unitek Orthodontic Products | 05/22/2023SE |
| K223141 | STR8 Clear AlignerNXC · Traditional | Str8 Oral Care | 04/24/2023SE |
| K223454 | Custom-made Invisible AlignersNXC · Traditional | Zhejiang Yinchili Medical Technology Co., Ltd. | 04/17/2023SE |
| K221537 | Nightwear AlignersNXC · Traditional | Smylio, Inc. | 04/05/2023SE |
| K222619 | EnsmileNXC · Traditional | Ensmile Pvt, Ltd. | 03/16/2023SE |
| K221845 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GNXC · Abbreviated | Blue Sky Bio, LLC | 02/24/2023SE |
| K223338 | Toothsi, SmilealignersNXC · Traditional | Makeo Healthcare Technologies Private Limited | 02/09/2023SE |
| K222894 | Invisalign System, Pre-Formed Attachment SystemNXC · Traditional | Align Technology, Inc. | 12/22/2022SE |
| K222308 | Al Smile AlignerNXC · Traditional | Nanjing Jiahe Dental Technology Co., Ltd. | 12/20/2022SE |
| K222918 | DentCare AlignersNXC · Traditional | Dentcare Dental Lab Pvt , Ltd. | 11/25/2022SE |
| K223355 | Tera Harz ClearNXC · Traditional | Graphy, Inc. | 11/03/2022SE |
| K211427 | CREOKORREKT AlignersNXC · Traditional | Creodent Prosthetics, Ltd. | 10/13/2022SE |
| K222418 | NuvolaNXC · Traditional | Gruppo Europeo Ortodonzia Srl | 10/07/2022SE |
| K220140 | ClearCorrect SystemNXC · Traditional | Clearcorrect, LLC | 10/05/2022SE |
| K221475 | MyClearALIGN Dental Aligner SystemNXC · Traditional | Key Dental Technologies, LLC | 08/31/2022SE |
| K213026 | Clear AlignerNXC · Traditional | Shenzhen Meiming Dentistry Technology Co., Ltd. | 08/16/2022SE |
| K220835 | ArklignersNXC · Traditional | Arklign Laboratories | 08/12/2022SE |
| K221097 | SmileSeriesNXC · Traditional | Ordont Orthodontic Laboratories, Inc. | 07/14/2022SE |
| K203624 | Custom-made Invisible AlignersNXC · Traditional | Zhejiang Yinchili Medical Technology Co., Ltd. | 06/16/2022SE |
| K212680 | LuxCreo Clear Aligner SystemNXC · Traditional | LuxCreo, Inc. | 05/31/2022SE |
| K212803 | DailyMate Orthodontic Aligner SystemNXC · Traditional | 3D Global Biotech, Inc. | 05/23/2022SE |
| K220287 | Invisalign SystemNXC · Special | Align Technology, Inc. | 04/07/2022SE |
| K220726 | K ClearNXC · Traditional | Kline Europe GmbH | 03/16/2022SE |
| K211510 | uLab Systems Dental Aligner KitNXC · Traditional | Ulab Systems, Inc. | 02/24/2022SE |
| K213297 | RedlineNXC · Traditional | Johns Dental Laboratories | 02/09/2022SE |
| K212772 | Precision AlignNXC · Traditional | Precision Align, LLC | 01/15/2022SE |
| K212496 | Ortho Aligner SystemNXC · Traditional | Ortho Lab Services, LLC | 11/04/2021SE |
| K211537 | QuickAlignersNXC · Traditional | Oral Image, Inc. | 10/26/2021SE |
| K203688 | Clear AlignerNXC · Traditional | Wuxi EA Medical Instruments Technologies Limited. | 10/08/2021SE |
| K210763 | Inman Digital Clear AlignersNXC · Traditional | Inman Orthodontic Laboratories, Inc. | 09/29/2021SE |
| K212660 | Smylio Invisible Clear AlignersNXC · Special | Smylio, Inc. | 09/22/2021SE |
| K212961 | SmilersNXC · Traditional | Biotech Dental Smilers, Sas | 09/20/2021SE |
| K210373 | Clear AlignersNXC · Traditional | Shenzhen Yinuo Dental Technology Co.Ltd | 08/27/2021SE |
| K210320 | ClearCorrect SystemNXC · Traditional | Clearcorrect, LLC | 08/06/2021SE |
| K193622 | TRIOCLEAR SystemNXC · Traditional | Perfection Aligner System Hong Kong Limited | 07/06/2021SE |
| K210613 | HIT Clear AlignerNXC · Special | Cdb Corporation | 06/04/2021SE |
| K210652 | 6MS Invisible AlignerNXC · Traditional | Sms Opco, LLC | 06/02/2021SE |
| K210540 | Ohlendorf Clear AlignerNXC · Traditional | Ohlendorf Appliance Laboratory | 05/19/2021SE |
| K211010 | Illusion AlignersNXC · Traditional | Laxmi Dental Exports Pvt, Ltd. | 04/26/2021SE |
| K211190 | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)NXC · Traditional | 3M Company, Unitek Orthodontic Products | 04/23/2021SE |
| K203737 | Spark Clear Aligner SystemNXC · Traditional | Ormco Corporation | 03/22/2021SE |
| K201104 | AsoAlignerNXC · Traditional | Aso International Manila, Inc. | 02/26/2021SE |
| K173738 | ArchworxNXC · Traditional | Utah Medical Products and Services | 02/26/2021SE |
| K202792 | BRIUS Clear AlignersNXC · Traditional | Brius Technologies, Inc. | 01/22/2021SE |
| K203339 | NEOLab Clear AlignersNXC · Special | New England Ortho Lab, Inc. | 01/06/2021SE |
| K202857 | ClearPath AlignerNXC · Traditional | Clearpath Orthodontics, Ltd. | 01/05/2021SE |
| K200908 | iSMILENXC · Traditional | 3D Diagnostix, Inc. | 12/22/2020SE |
| K193385 | TP Orthodontics Clear Aligner SystemNXC · Traditional | Tp Orthodontics, Inc. | 11/12/2020SE |
| K200005 | Concinnity AlignersNXC · Traditional | Drake Precision Dental Laboratory, Inc. | 11/09/2020SE |
| K202685 | Eon AlignerNXC · Traditional | Eon Dental Jordan, LLC | 09/28/2020SE |
| K201450 | Straight T Clear Dental AlignerNXC · Traditional | Straight T, Inc. | 09/10/2020SE |
| K193130 | MVP Aligner SystemNXC · Traditional | Mvp Aligners, LLC | 08/07/2020SE |
| K192244 | Arcad SmileStudio and Aligner SystemNXC · Traditional | Arcadlab | 05/11/2020SE |
| K192069 | Aerodentis SystemNXC · Traditional | Dror Orthodesign | 05/06/2020SE |
| K191308 | U-AlignerNXC · Traditional | Universal Orthodontic Laboratory, Inc. | 04/23/2020SE |
| K191838 | Clearform AlignersNXC · Traditional | Motor City Lab Works | 03/20/2020SE |
| K192338 | NEOLab Clear AlignersNXC · Traditional | New England Ortho Lab, Inc. | 03/12/2020SE |
| K200214 | 3D PredictNXC · Traditional | 3D Smile USA, Inc. | 02/24/2020SE |
| K192596 | ULab Systems Dental Aligner KitNXC · Traditional | Ulab Systems, Inc. | 02/11/2020SE |
| K192846 | Argen Clear Aligner, Argen Clear Aligner PremiumNXC · Special | Argen Corporation | 02/10/2020SE |
| K191837 | UniSmile Clear Aligner SystemNXC · Traditional | Vitang Technology, LLC | 01/29/2020SE |
| K192767 | Clear AlignerNXC · Traditional | Royal Dental Lab | 01/08/2020SE |
| K192470 | DenMat Orthodontic AlignersNXC · Traditional | Denmat Holdings, LLC | 12/20/2019SE |
| K191823 | Clear-AlignersNXC · Traditional | Cdb Corporation | 12/20/2019SE |
| K182388 | Krystal Klear AlignersNXC · Traditional | Shatkin F.I.R.S.T., LLC | 12/19/2019SE |
| K190394 | SunClear Aligner systemNXC · Traditional | Sun Dental Laboratories, LLC | 12/16/2019SE |
| K190003 | Vivid AlignersNXC · Traditional | Orthodent Laboratory, Inc. | 11/06/2019SE |
| K191774 | SmileAlign Orthodontic Aligner SystemNXC · Traditional | 3D Global Biotech, Inc. | 09/30/2019SE |
| K192119 | 3M Clarity AlignersNXC · Traditional | 3M Company | 09/05/2019SE |
| K191990 | OSW Aligner SystemNXC · Traditional | Osw Manufacturing, LLC | 08/23/2019SE |
| K190583 | DynaFlexNXC · Traditional | Dyna Flex | 06/27/2019SE |
| K182658 | BiolinerNXC · Traditional | Five Star Orthodontic Lab & Supply | 06/19/2019SE |
| K183229 | Argen Clear AlignerNXC · Traditional | Argen Corporation | 06/07/2019SE |
| K190948 | Magic Clear AlignersNXC · Traditional | Voodoo Manufacturing, Inc. | 05/09/2019SE |
| K181747 | Orthodontic ApplianceNXC · Traditional | Shandong Huge Dental Material Corporation | 04/18/2019SE |
| K180346 | Byte Aligner SystemNXC · Traditional | Straight Smile, LLC | 02/19/2019SE |
| K180648 | Park Dental Research AlignersNXC · Traditional | Park Dental Research Corporation | 01/08/2019SE |
| K183643 | Clear Image AlignersNXC · Traditional | Specialty Appliance Works, Inc. | 01/03/2019SE |
| K183159 | 3M Clarity AlignersNXC · Traditional | 3M Company | 11/26/2018SE |
| K182329 | SureCure Orthodontic Aligner SystemNXC · Traditional | Digital Orthodontic Care | 11/08/2018SE |
| K181739 | Invisalign System with Mandibular Advancement FeatureNXC · Traditional | Align Technology, Inc. | 10/26/2018SE |
| K182826 | Ormco Spark Aligner SystemNXC · Traditional | Sybron Dental Specialties | 10/11/2018SE |
| K180241 | Orthocaps TwinalignerNXC · Traditional | Ortho Caps GmbH | 09/28/2018SE |
| K173784 | Smylic Invisible Clear AlignersNXC · Traditional | Smylio, Inc. | 08/23/2018SE |
| K172765 | Smart Moves CompleteNXC · Traditional | Great Lakes Orthodontics, Ltd. | 06/01/2018SE |
| K173785 | Custom Clear Aligner SystemNXC · Traditional | Derby Dental Laboratory | 03/13/2018SE |
| K180107 | Blue Sky Bio AlignerNXC · Traditional | Blue Sky Bio, LLC | 02/09/2018SE |
| K171674 | Angel Align SystemNXC · Traditional | Smile Development Corp | 01/19/2018SE |
| K171860 | Sureclear alignersNXC · Traditional | Emergo Global Consulting, LLC | 01/05/2018SE |
| K162609 | ClearPath AlignerNXC · Traditional | Clearpath Orthodontics, Ltd. | 07/06/2017SE |
| K163155 | MTM Clear AlignerNXC · Traditional | Dentsply Sirona | 02/03/2017SE |
| K163689 | 3M Clear Tray AlignerNXC · Traditional | 3M Unitek Corporation | 01/27/2017SE |
| K151965 | Dentti SystemNXC · Traditional | Martz, Inc. | 03/11/2016SE |
| K143630 | Invisalign SystemNXC · Traditional | Align Technology, Inc. | 11/18/2015SE |
| K143499 | eClignerNXC · Traditional | Eclear International Co., Ltd. | 10/09/2015SE |
| K123514 | Clearpath AlignerNXC · Traditional | Qserve America, Inc. | 11/01/2013SE |
| K132145 | Mtm(R) Clear AlignerNXC · Traditional | Dentsply International, Inc. | 10/11/2013SE |
| K123925 | MTM Clear Aligner In-OfficeNXC · Traditional | Dentsply International, Inc. | 05/24/2013SE |
| K130237 | Pontic PaintNXC · Traditional | Reliance Orthodontic Products, Inc. | 04/05/2013SE |
| K121396 | DynaflexNXC · Traditional | Dyna Flex | 08/14/2012SE |
| K113618 | Clearcorrect SystemNXC · Traditional | Clearcorrect, Inc. | 03/19/2012SE |
| K093821 | FS AlignerNXC · Traditional | Allesee Orthodontic Appliances | 08/27/2010SE |
| K073121 | Nubrace Invisible Removable OrthodonticsNXC · Traditional | Nubrace, Inc. | 02/12/2009SE |
| K082556 | ClearcorrectNXC · Traditional | Clearcorrect, Inc. | 02/06/2009SE |
| K081960 | Invisalign SystemNXC · Traditional | Align Technology | 12/17/2008SE |
| K080246 | Composite Aligner ButtonNXC · Traditional | Dentsply Interntional | 04/11/2008SE |
| K071970 | Clear Image AlignerNXC · Traditional | Specialty Appliance Works, Inc. | 09/25/2007SE |
| K040874 | Red, White & BlueNXC · Traditional | Allesee Orthodontic Appliances | 06/18/2004SE |
| K981095 | Align SystemNXC · Traditional | Align Technology | 09/08/1998SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0743-2025 Class II | Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs:…Attachments may not mate with the tooth as intended in the digital treatment design. | 3M Company - Health Care Business | 11/22/2024Open, Classified |
| Z-0750-2025 Class II | BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner…Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner… | Straight Smile, LLC | 11/04/2024Open, Classified |