K240501 is an FDA 510(k) clearance for the Spark™ Clear Aligner System. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Ormco Corporation (Brea, US). The FDA issued a Cleared decision on October 11, 2024, 233 days after receiving the submission on February 21, 2024.
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 | K240501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2024 |
| Decision Date | October 11, 2024 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| 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. |