NXC
- Product code
- NXC
- Device name
- Aligner, Sequential
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.5470
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 34
- Summaries archived here
- 27 (direct download)
- 510(k) clearances (all years, FDA)
- 145 (all years; only the last 3 years are listed here)
FDA classification definition
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
510(k) clearances, last 3 years (34)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260527 | 2026-07-02 | Avinent Implant System S.L.U. | FACE4D Aligner | FDA |
| K260788 | 2026-05-08 | Smylio, Inc. | Smylio Aligners | — |
| K260722 | 2026-04-15 | Dentsply Sirona, Inc. | SureSmile Aligner (ASSY500020) | |
| K253282 | 2026-02-03 | Dror Orthodesign , Ltd. | ZSmile System | |
| K251454 | 2026-01-07 | Beame Medical Technology (Shenzhen) Li… | Clear Aligner (SCF-3348) | |
| K250739 | 2025-11-07 | Dreve Dentamid GmbH | Primeprint Direct Aligner | |
| K252931 | 2025-10-23 | Align Technology, Inc. | Invisalign® Palatal Expander System | |
| K252870 | 2025-10-09 | Align Technology, Inc. | Invisalign Specifix Attachment System | |
| K251758 | 2025-09-11 | Tns Co., Ltd. | Serafin® | |
| K252380 | 2025-08-29 | Align Technology, Inc. | Invisalign System | |
| K251415 | 2025-08-27 | Aidite (Qinhuangdao) Technology Co., L… | Additively Manufactured Aligner Resin | |
| K251616 | 2025-07-22 | Ods Co., Ltd. | Clear Miracle | FDA |
| K242637 | 2025-05-21 | Mem Dental Technology Co., Ltd. | MEM Clear Aligner System | |
| K250343 | 2025-04-08 | LuxCreo, Inc. | LuxCreo Clear Aligner System | |
| K250487 | 2025-02-20 | Ormco Corporation | SparkTM Clear Aligner System | |
| K242715 | 2025-01-16 | Pearl Digital, Inc. | Pearl Clear Aligner | FDA |
| K242929 | 2024-12-20 | Xplora 3D Europe S.L | Fas Aligner System | |
| K242892 | 2024-12-19 | Cristaline Aligners GmbH | Cristaline Aligners Z FLX | |
| K233152 | 2024-12-12 | Geniova Technologies Sociedad Limitada | GENIOVA aligners | FDA |
| K240501 | 2024-10-11 | Ormco Corporation | Spark Clear Aligner System | |
| K233356 | 2024-08-08 | Laxmi Dental Export Pvt., Ltd. | Illusion Aligner Pro: Illusion Aligner FLX | |
| K241137 | 2024-08-01 | Clear Moves Aligners | Clear Moves Aligner | |
| K241187 | 2024-07-26 | Alien Milling Technologies | Alien Aligners | FDA |
| K241412 | 2024-06-18 | Align Technology, Inc. | Invisalign System | |
| K233935 | 2024-04-05 | Park Dental Research Corporation | DigiLine Direct Print Aligner System | |
| K240038 | 2024-04-04 | Space Maintainers Laboratories (Sml) | Clear Moves Aligners | |
| K232653 | 2024-04-03 | Blue Sky Bio, LLC | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and … | |
| K240597 | 2024-03-05 | Graphy, Inc. | TERA HARZ CLEAR | FDA |
| K233544 | 2024-02-22 | Dentis Co., Ltd. | MESHEET | |
| K232074 | 2024-02-22 | Tns Co., Ltd. | Serafin® | |
| K232887 | 2023-12-15 | Align Technology, Inc. | Invisalign Palatal Expander System | |
| K230199 | 2023-10-18 | Dentsply Sirona, Inc. | Byte Aligner System | |
| K233257 | 2023-09-29 | 3M Company, Unitek Orthodontic Product… | 3M ClarityAligners with Quick Attachments | |
| K232233 | 2023-09-26 | Align Technology, Inc. | Invisalign System with Mandibular Advancement Featur… |
Official FDA classification page: NXC
Classification and pathway per current FDA publications. Data from openFDA (CC0).