K233257 is an FDA 510(k) clearance for the 3M™ Clarity™Aligners with Quick Attachments. 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 September 29, 2023, 1 day after receiving the submission on September 28, 2023.
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 | K233257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | September 29, 2023 |
| Days to Decision | 1 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. |