K212772 is an FDA 510(k) clearance for the Precision Align. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Precision Align, LLC (Fort Lauderdale, US). The FDA issued a Cleared decision on January 15, 2022, 137 days after receiving the submission on August 31, 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 | K212772 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2021 |
| Decision Date | January 15, 2022 |
| Days to Decision | 137 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. |