K233152 is an FDA 510(k) clearance for the GENIOVA aligners. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Geniova Technologies Sociedad Limitada (Madrid, ES). The FDA issued a Cleared decision on December 12, 2024, 442 days after receiving the submission on September 27, 2023.
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 | K233152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2023 |
| Decision Date | December 12, 2024 |
| Days to Decision | 442 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. |