K201104 is an FDA 510(k) clearance for the AsoAligner. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Aso International Manila, Inc. (Cavite, PH). The FDA issued a Cleared decision on February 26, 2021, 308 days after receiving the submission on April 24, 2020.
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 | K201104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2020 |
| Decision Date | February 26, 2021 |
| Days to Decision | 308 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. |