K222418 is an FDA 510(k) clearance for the Nuvola. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Gruppo Europeo Ortodonzia Srl (Rome, IT). The FDA issued a Cleared decision on October 7, 2022, 58 days after receiving the submission on August 10, 2022.
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 | K222418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2022 |
| Decision Date | October 07, 2022 |
| Days to Decision | 58 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. |