K221845 is an FDA 510(k) clearance for the Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Blue Sky Bio, LLC (Libertyville, US). The FDA issued a Cleared decision on February 24, 2023, 245 days after receiving the submission on June 24, 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 | K221845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2022 |
| Decision Date | February 24, 2023 |
| Days to Decision | 245 days |
| Submission Type | Abbreviated |
| 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. |