The following data is part of a premarket notification filed by Southern Implants (pty) Ltd with the FDA for Zygomatic Implant System.
| Device ID | K173343 |
| 510k Number | K173343 |
| Device Name: | Zygomatic Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Southern Implants (Pty) Ltd 1 Albert Road Irene, ZA 0062 |
| Contact | Lauranda G. Breytenbach |
| Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-24 |
| Decision Date | 2018-02-27 |
| Summary: | summary |