Aligner, Sequential
Regulation 872.5470
6510(k)s in 12 months (145 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in NXC
| Company | 510(k)s | Recalls |
|---|---|---|
| Align Technology | 12 | 0 |
| Clearcorrect, Inc. | 4 | 0 |
| Smylio, Inc. | 4 | 0 |
| 3M Company, Unitek Orthodontic Products | 3 | 0 |
| Blue Sky Bio, LLC | 3 | 0 |
| Dentsply Sirona | 3 | 0 |
| Ormco Corporation | 3 | 0 |
| 3D Global Biotech, Inc. | 2 | 0 |
| 3M Company | 2 | 0 |
| Allesee Orthodontic Appliances | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 31, 2022 | K221475 | MyClearALIGN Dental Aligner System Key Dental Technologies, LLC | NXC |
| Aug 16, 2022 | K213026 | Clear Aligner Shenzhen Meiming Dentistry Technology Co., Ltd., CN | NXC |
| Aug 12, 2022 | K220835 | Arkligners Arklign Laboratories | NXC |
| Jul 14, 2022 | K221097 | SmileSeries Ordont Orthodontic Laboratories, Inc. | NXC |
| Jun 16, 2022 | K203624 | Custom-made Invisible Aligners Zhejiang Yinchili Medical Technology Co., Ltd., CN | NXC |
| May 31, 2022 | K212680 | LuxCreo Clear Aligner System LuxCreo, Inc. | NXC |
| May 23, 2022 | K212803 | DailyMate Orthodontic Aligner System 3D Global Biotech, Inc., TW | NXC |
| Apr 7, 2022 | K220287 | Invisalign System Align Technology, Inc. | NXC |
| Mar 16, 2022 | K220726 | K Clear Kline Europe GmbH, DE | NXC |
| Feb 24, 2022 | K211510 | uLab Systems Dental Aligner Kit Ulab Systems, Inc. | NXC |
| Feb 9, 2022 | K213297 | Redline Johns Dental Laboratories | NXC |
| Jan 15, 2022 | K212772 | Precision Align Precision Align, LLC | NXC |
| Nov 4, 2021 | K212496 | Ortho Aligner System Ortho Lab Services, LLC | NXC |
| Oct 26, 2021 | K211537 | QuickAligners Oral Image, Inc. | NXC |
| Oct 8, 2021 | K203688 | Clear Aligner Wuxi EA Medical Instruments Technologies Limited., CN | NXC |
| Sep 29, 2021 | K210763 | Inman Digital Clear Aligners Inman Orthodontic Laboratories, Inc. | NXC |
| Sep 22, 2021 | K212660 | Smylio Invisible Clear Aligners Smylio, Inc. | NXC |
| Sep 20, 2021 | K212961 | SMILERS Biotech Dental Smilers, Sas, FR | NXC |
| Aug 27, 2021 | K210373 | Clear Aligners Shenzhen Yinuo Dental Technology Co.Ltd, CN | NXC |
| Aug 6, 2021 | K210320 | ClearCorrect System Clearcorrect, LLC | NXC |
| Jul 6, 2021 | K193622 | TRIOCLEAR System Perfection Aligner System Hong Kong Limited, HK | NXC |
| Jun 4, 2021 | K210613 | HIT Clear Aligner Cdb Corporation | NXC |
| Jun 2, 2021 | K210652 | 6MS Invisible Aligner Sms Opco, LLC | NXC |
| May 19, 2021 | K210540 | Ohlendorf Clear Aligner Ohlendorf Appliance Laboratory | NXC |
| Apr 26, 2021 | K211010 | Illusion Aligners Laxmi Dental Exports Pvt, Ltd., IN | NXC |
| Apr 23, 2021 | K211190 | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) 3M Company, Unitek Orthodontic Products | NXC |
| Mar 22, 2021 | K203737 | Spark Clear Aligner System Ormco Corporation | NXC |
| Feb 26, 2021 | K201104 | AsoAligner Aso International Manila, Inc., PH | NXC |
| Feb 26, 2021 | K173738 | Archworx Utah Medical Products and Services | NXC |
| Jan 22, 2021 | K202792 | BRIUS Clear Aligners Brius Technologies, Inc. | NXC |
| Jan 6, 2021 | K203339 | NEOLab Clear Aligners New England Ortho Lab, Inc. | NXC |
| Jan 5, 2021 | K202857 | ClearPath Aligner Clearpath Orthodontics, Ltd., PK | NXC |
| Dec 22, 2020 | K200908 | iSMILE 3D Diagnostix, Inc. | NXC |
| Nov 12, 2020 | K193385 | TP Orthodontics Clear Aligner System Tp Orthodontics, Inc. | NXC |
| Nov 9, 2020 | K200005 | Concinnity Aligners Drake Precision Dental Laboratory, Inc. | NXC |
| Sep 28, 2020 | K202685 | Eon Aligner Eon Dental Jordan, LLC, JO | NXC |
| Sep 10, 2020 | K201450 | Straight T Clear Dental Aligner Straight T, Inc. | NXC |
| Aug 7, 2020 | K193130 | MVP Aligner System Mvp Aligners, LLC | NXC |
| May 11, 2020 | K192244 | Arcad SmileStudio and Aligner System Arcadlab | NXC |
| May 6, 2020 | K192069 | Aerodentis System Dror Orthodesign, IL | NXC |
| Apr 23, 2020 | K191308 | U-Aligner Universal Orthodontic Laboratory, Inc. | NXC |
| Mar 20, 2020 | K191838 | Clearform Aligners Motor City Lab Works | NXC |
| Mar 12, 2020 | K192338 | NEOLab Clear Aligners New England Ortho Lab, Inc. | NXC |
| Feb 24, 2020 | K200214 | 3D Predict 3D Smile USA, Inc. | NXC |
| Feb 11, 2020 | K192596 | ULab Systems Dental Aligner Kit Ulab Systems, Inc. | NXC |
| Feb 10, 2020 | K192846 | Argen Clear Aligner, Argen Clear Aligner Premium Argen Corporation | NXC |
| Jan 29, 2020 | K191837 | UniSmile Clear Aligner System Vitang Technology, LLC | NXC |
| Jan 8, 2020 | K192767 | Clear Aligner Royal Dental Lab, CN | NXC |
| Dec 20, 2019 | K192470 | DenMat Orthodontic Aligners Denmat Holdings, LLC | NXC |
| Dec 20, 2019 | K191823 | Clear-Aligners Cdb Corporation | NXC |
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