NXC
145 FDA 510(k) clearances · Product code
128 daysmedian time to decision
313 days90th percentile
145clearances measured
FDA profile
- Official device name
- Aligner, Sequential
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5470
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- FDA definition
- The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
- Adverse events (MAUDE)
- 2021: 929 · 2022: 605 · 2023: 433 · 2024: 8,992 · 2025: 4,578 · 2026: 2,303
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FACE4D Aligner (K260527) | Avinent Implant System S.L.U. | 2026-07-02 |
| Smylio Aligners (K260788) | Smylio, Inc. | 2026-05-08 |
| SureSmile Aligner (ASSY500020) (K260722) | Dentsply Sirona, Inc. | 2026-04-15 |
| ZSmile System (K253282) | Dror Orthodesign , Ltd. | 2026-02-03 |
| Clear Aligner (SCF-3348) (K251454) | Beame Medical Technology (Shenzhen) Limited | 2026-01-07 |
| Primeprint Direct Aligner (K250739) | Dreve Dentamid GmbH | 2025-11-07 |
| Invisalign® Palatal Expander System (K252931) | Align Technology, Inc. | 2025-10-23 |
| Invisalign Specifix Attachment System (K252870) | Align Technology, Inc. | 2025-10-09 |
| Serafin® (K251758) | Tns Co., Ltd. | 2025-09-11 |
| Invisalign System (K252380) | Align Technology, Inc. | 2025-08-29 |
| Additively Manufactured Aligner Resin (K251415) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-08-27 |
| Clear Miracle (K251616) | Ods Co., Ltd. | 2025-07-22 |
| MEM Clear Aligner System (K242637) | Mem Dental Technology Co., Ltd. | 2025-05-21 |
| LuxCreo Clear Aligner System (K250343) | LuxCreo, Inc. | 2025-04-08 |
| SparkTM Clear Aligner System (K250487) | Ormco Corporation | 2025-02-20 |
| Pearl Clear Aligner (K242715) | Pearl Digital, Inc. | 2025-01-16 |
| Fas Aligner System (K242929) | Xplora 3D Europe S.L | 2024-12-20 |
| Cristaline Aligners Z FLX (K242892) | Cristaline Aligners GmbH | 2024-12-19 |
| GENIOVA aligners (K233152) | Geniova Technologies Sociedad Limitada | 2024-12-12 |
| Spark™ Clear Aligner System (K240501) | Ormco Corporation | 2024-10-11 |
| Illusion Aligner Pro: Illusion Aligner FLX (K233356) | Laxmi Dental Export Pvt., Ltd. | 2024-08-08 |
| Clear Moves Aligner (K241137) | Clear Moves Aligners | 2024-08-01 |
| Alien Aligners (K241187) | Alien Milling Technologies | 2024-07-26 |
| Invisalign System (K241412) | Align Technology, Inc. | 2024-06-18 |
| DigiLine Direct Print Aligner System (K233935) | Park Dental Research Corporation | 2024-04-05 |
| Clear Moves Aligners (K240038) | Space Maintainers Laboratories (Sml) | 2024-04-04 |
| Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX (K232653) | Blue Sky Bio, LLC | 2024-04-03 |
| TERA HARZ CLEAR (K240597) | Graphy, Inc. | 2024-03-05 |
| MESHEET (K233544) | Dentis Co., Ltd. | 2024-02-22 |
| Serafin® (K232074) | Tns Co., Ltd. | 2024-02-22 |
| Invisalign Palatal Expander System (K232887) | Align Technology, Inc. | 2023-12-15 |
| Byte Aligner System (K230199) | Dentsply Sirona, Inc. | 2023-10-18 |
| 3M™ Clarity™Aligners with Quick Attachments (K233257) | 3M Company, Unitek Orthodontic Products | 2023-09-29 |
| Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (K232233) | Align Technology, Inc. | 2023-09-26 |
| TRIOCLEAR System (K231884) | Modern Dental Laboratory (Dg) Co., Ltd. | 2023-09-01 |
| Clear Aligner (K223517) | Wuxi EA Medical Instruments Technologies Limited. | 2023-06-13 |
| 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) (K231464) | 3M Company, Unitek Orthodontic Products | 2023-05-22 |
| STR8 Clear Aligner (K223141) | Str8 Oral Care | 2023-04-24 |
| Custom-made Invisible Aligners (K223454) | Zhejiang Yinchili Medical Technology Co., Ltd. | 2023-04-17 |
| Nightwear Aligners (K221537) | Smylio, Inc. | 2023-04-05 |
| Ensmile (K222619) | Ensmile Pvt, Ltd. | 2023-03-16 |
| Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G (K221845) | Blue Sky Bio, LLC | 2023-02-24 |
| Toothsi, Smilealigners (K223338) | Makeo Healthcare Technologies Private Limited | 2023-02-09 |
| Invisalign System, Pre-Formed Attachment System (K222894) | Align Technology, Inc. | 2022-12-22 |
| Al Smile Aligner (K222308) | Nanjing Jiahe Dental Technology Co., Ltd. | 2022-12-20 |
| DentCare Aligners (K222918) | Dentcare Dental Lab Pvt , Ltd. | 2022-11-25 |
| Tera Harz Clear (K223355) | Graphy, Inc. | 2022-11-03 |
| CREOKORREKT Aligners (K211427) | Creodent Prosthetics, Ltd. | 2022-10-13 |
| Nuvola (K222418) | Gruppo Europeo Ortodonzia Srl | 2022-10-07 |
| ClearCorrect System (K220140) | Clearcorrect, LLC | 2022-10-05 |
| MyClearALIGN Dental Aligner System (K221475) | Key Dental Technologies, LLC | 2022-08-31 |
| Clear Aligner (K213026) | Shenzhen Meiming Dentistry Technology Co., Ltd. | 2022-08-16 |
| Arkligners (K220835) | Arklign Laboratories | 2022-08-12 |
| SmileSeries (K221097) | Ordont Orthodontic Laboratories, Inc. | 2022-07-14 |
| Custom-made Invisible Aligners (K203624) | Zhejiang Yinchili Medical Technology Co., Ltd. | 2022-06-16 |
| LuxCreo Clear Aligner System (K212680) | LuxCreo, Inc. | 2022-05-31 |
| DailyMate Orthodontic Aligner System (K212803) | 3D Global Biotech, Inc. | 2022-05-23 |
| Invisalign System (K220287) | Align Technology, Inc. | 2022-04-07 |
| K Clear (K220726) | Kline Europe GmbH | 2022-03-16 |
| uLab Systems Dental Aligner Kit (K211510) | Ulab Systems, Inc. | 2022-02-24 |
| Redline (K213297) | Johns Dental Laboratories | 2022-02-09 |
| Precision Align (K212772) | Precision Align, LLC | 2022-01-15 |
| Ortho Aligner System (K212496) | Ortho Lab Services, LLC | 2021-11-04 |
| QuickAligners (K211537) | Oral Image, Inc. | 2021-10-26 |
| Clear Aligner (K203688) | Wuxi EA Medical Instruments Technologies Limited. | 2021-10-08 |
| Inman Digital Clear Aligners (K210763) | Inman Orthodontic Laboratories, Inc. | 2021-09-29 |
| Smylio Invisible Clear Aligners (K212660) | Smylio, Inc. | 2021-09-22 |
| SMILERS (K212961) | Biotech Dental Smilers, Sas | 2021-09-20 |
| Clear Aligners (K210373) | Shenzhen Yinuo Dental Technology Co.Ltd | 2021-08-27 |
| ClearCorrect System (K210320) | Clearcorrect, LLC | 2021-08-06 |
| TRIOCLEAR System (K193622) | Perfection Aligner System Hong Kong Limited | 2021-07-06 |
| HIT Clear Aligner (K210613) | Cdb Corporation | 2021-06-04 |
| 6MS Invisible Aligner (K210652) | Sms Opco, LLC | 2021-06-02 |
| Ohlendorf Clear Aligner (K210540) | Ohlendorf Appliance Laboratory | 2021-05-19 |
| Illusion Aligners (K211010) | Laxmi Dental Exports Pvt, Ltd. | 2021-04-26 |
| 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) (K211190) | 3M Company, Unitek Orthodontic Products | 2021-04-23 |
| Spark Clear Aligner System (K203737) | Ormco Corporation | 2021-03-22 |
| AsoAligner (K201104) | Aso International Manila, Inc. | 2021-02-26 |
| Archworx (K173738) | Utah Medical Products and Services | 2021-02-26 |
| BRIUS Clear Aligners (K202792) | Brius Technologies, Inc. | 2021-01-22 |
| NEOLab Clear Aligners (K203339) | New England Ortho Lab, Inc. | 2021-01-06 |
| ClearPath Aligner (K202857) | Clearpath Orthodontics, Ltd. | 2021-01-05 |
| iSMILE (K200908) | 3D Diagnostix, Inc. | 2020-12-22 |
| TP Orthodontics Clear Aligner System (K193385) | Tp Orthodontics, Inc. | 2020-11-12 |
| Concinnity Aligners (K200005) | Drake Precision Dental Laboratory, Inc. | 2020-11-09 |
| Eon Aligner (K202685) | Eon Dental Jordan, LLC | 2020-09-28 |
| Straight T Clear Dental Aligner (K201450) | Straight T, Inc. | 2020-09-10 |
| MVP Aligner System (K193130) | Mvp Aligners, LLC | 2020-08-07 |
| Arcad SmileStudio and Aligner System (K192244) | Arcadlab | 2020-05-11 |
| Aerodentis System (K192069) | Dror Orthodesign | 2020-05-06 |
| U-Aligner (K191308) | Universal Orthodontic Laboratory, Inc. | 2020-04-23 |
| Clearform Aligners (K191838) | Motor City Lab Works | 2020-03-20 |
| NEOLab Clear Aligners (K192338) | New England Ortho Lab, Inc. | 2020-03-12 |
| 3D Predict (K200214) | 3D Smile USA, Inc. | 2020-02-24 |
| ULab Systems Dental Aligner Kit (K192596) | Ulab Systems, Inc. | 2020-02-11 |
| Argen Clear Aligner, Argen Clear Aligner Premium (K192846) | Argen Corporation | 2020-02-10 |
| UniSmile Clear Aligner System (K191837) | Vitang Technology, LLC | 2020-01-29 |
| Clear Aligner (K192767) | Royal Dental Lab | 2020-01-08 |
| Clear-Aligners (K191823) | Cdb Corporation | 2019-12-20 |
| DenMat Orthodontic Aligners (K192470) | Denmat Holdings, LLC | 2019-12-20 |
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