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