K192846 is an FDA 510(k) clearance for the Argen Clear Aligner, Argen Clear Aligner Premium. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Argen Corporation (San Diego, US). The FDA issued a Cleared decision on February 10, 2020, 130 days after receiving the submission on October 3, 2019.
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 | K192846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2019 |
| Decision Date | February 10, 2020 |
| Days to Decision | 130 days |
| Submission Type | Special |
| 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. |