K192069 is an FDA 510(k) clearance for the Aerodentis System. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Dror Orthodesign (Jerusalem, IL). The FDA issued a Cleared decision on May 6, 2020, 279 days after receiving the submission on August 1, 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 | K192069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2019 |
| Decision Date | May 06, 2020 |
| Days to Decision | 279 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. |