The following data is part of a premarket notification filed by Southern Implants (pty) Ltd with the FDA for Zaga Zygomatic System.
| Device ID | K222497 |
| 510k Number | K222497 |
| Device Name: | Zaga Zygomatic System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Southern Implants (Pty) Ltd 1 Albert Road Irene, ZA 0062 |
| Contact | Leith C. Cumming |
| Correspondent | Leith C. Cumming Southern Implants (Pty) Ltd 1 Albert Road Irene, ZA 0062 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-18 |
| Decision Date | 2022-11-09 |