The following data is part of a premarket notification filed by Swift Health Systems, Inc. with the FDA for Inbrace Orthodontic System.
| Device ID | K203442 |
| 510k Number | K203442 |
| Device Name: | Inbrace Orthodontic System |
| Classification | Orthodontic Software |
| Applicant | Swift Health Systems, Inc. 111 Academy, Suite 150 Irvine, CA 92617 |
| Contact | Alicia Mszyca |
| Correspondent | Alicia Mszyca Swift Health Systems, Inc. 111 Academy, Suite 150 Irvine, CA 92617 |
| Product Code | PNN |
| Subsequent Product Code | DZC |
| Subsequent Product Code | EJF |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-23 |
| Decision Date | 2021-02-19 |