The following data is part of a premarket notification filed by Dror Orthodesign with the FDA for Aerodentis System.
| Device ID | K192069 |
| 510k Number | K192069 |
| Device Name: | Aerodentis System |
| Classification | Aligner, Sequential |
| Applicant | Dror Orthodesign 7 Hartom St., Mount Hotzvim Jerusalem, IL 9777507 |
| Contact | Michael Nadav |
| Correspondent | Janice M. Hogan Hogan Lovelle US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-01 |
| Decision Date | 2020-05-06 |