K211537 is an FDA 510(k) clearance for the QuickAligners. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Oral Image, Inc. (San Diego, US). The FDA issued a Cleared decision on October 26, 2021, 161 days after receiving the submission on May 18, 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 | K211537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2021 |
| Decision Date | October 26, 2021 |
| Days to Decision | 161 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. |