K211190 is an FDA 510(k) clearance for the 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex). This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by 3M Company, Unitek Orthodontic Products (Saint Paul, US). The FDA issued a Cleared decision on April 23, 2021, 2 days after receiving the submission on April 21, 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 | K211190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2021 |
| Decision Date | April 23, 2021 |
| Days to Decision | 2 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. |