NXC — Aligner, Sequential Class II
FDA product code NXC covers "Aligner, Sequential", a Class II medical device regulated under 21 CFR 872.5470. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NXC
- Device Class
- Class II
- Regulation Number
- 872.5470
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260527 | avinent implant system s.l.u | FACE4D Aligner | July 2, 2026 |
| K260788 | smylio | Smylio Aligners | May 8, 2026 |
| K260722 | dentsply sirona | SureSmile Aligner (ASSY500020) | April 15, 2026 |
| K253282 | dror orthodesign | ZSmile System | February 3, 2026 |
| K251454 | beame medical technology (shenzhen) limited | Clear Aligner (SCF-3348) | January 7, 2026 |
| K250739 | dreve dentamid | Primeprint Direct Aligner | November 7, 2025 |
| K252931 | align technology | Invisalign® Palatal Expander System | October 23, 2025 |
| K252870 | align technology | Invisalign Specifix Attachment System | October 9, 2025 |
| K251758 | tns co | Serafin® | September 11, 2025 |
| K252380 | align technology | Invisalign System | August 29, 2025 |
| K251415 | aidite (qinhuangdao) technology co | Additively Manufactured Aligner Resin | August 27, 2025 |
| K251616 | ods co | Clear Miracle | July 22, 2025 |
| K242637 | mem dental technology co | MEM Clear Aligner System | May 21, 2025 |
| K250343 | luxcreo | LuxCreo Clear Aligner System | April 8, 2025 |
| K250487 | ormco corporation | SparkTM Clear Aligner System | February 20, 2025 |
| K242715 | pearl digital | Pearl Clear Aligner | January 16, 2025 |
| K242929 | xplora 3d europe s.l | Fas Aligner System | December 20, 2024 |
| K242892 | cristaline aligners | Cristaline Aligners Z FLX | December 19, 2024 |
| K233152 | geniova technologies sociedad limitada | GENIOVA aligners | December 12, 2024 |
| K240501 | ormco corporation | Spark Clear Aligner System | October 11, 2024 |