K252931 is an FDA 510(k) clearance for the Invisalign® Palatal Expander System. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Align Technology, Inc. (San Jose, US). The FDA issued a Cleared decision on October 23, 2025, 38 days after receiving the submission on September 15, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion..
| 510(k) Number | K252931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2025 |
| Decision Date | October 23, 2025 |
| Days to Decision | 38 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NXC - Aligner, Sequential |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion. |