NXC — Aligner, Sequential Class II
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 |
|---|---|---|---|
| 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 |
| K233356 | laxmi dental export pvt | Illusion Aligner Pro: Illusion Aligner FLX | August 8, 2024 |
| K241137 | clear moves aligners | Clear Moves Aligner | August 1, 2024 |
| K241187 | alien milling technologies | Alien Aligners | July 26, 2024 |