K211510 is an FDA 510(k) clearance for the uLab Systems Dental Aligner Kit. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Ulab Systems, Inc. (San Mateo, US). The FDA issued a Cleared decision on February 24, 2022, 286 days after receiving the submission on May 14, 2021.
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 | K211510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2021 |
| Decision Date | February 24, 2022 |
| Days to Decision | 286 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. |