The following data is part of a premarket notification filed by Southern Implants (pty) Ltd with the FDA for Zaga Zygomatic System.
| Device ID | K192651 |
| 510k Number | K192651 |
| Device Name: | ZAGA Zygomatic System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Southern Implants (Pty) Ltd 1 Albert Road Irene, ZA 0062 |
| Contact | Lauranda G Breytenbach |
| Correspondent | Lauranda G Breytenbach 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 | 2019-09-24 |
| Decision Date | 2020-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009544034735 | K192651 | 000 |
| 06009544034841 | K192651 | 000 |
| 06009544034834 | K192651 | 000 |
| 06009544034827 | K192651 | 000 |
| 06009544034797 | K192651 | 000 |
| 06009544034780 | K192651 | 000 |
| 06009544034773 | K192651 | 000 |
| 06009544034742 | K192651 | 000 |
| 06009544035114 | K192651 | 000 |
| 06009544035107 | K192651 | 000 |
| 06009544035091 | K192651 | 000 |
| 06009544035084 | K192651 | 000 |
| 06009544034759 | K192651 | 000 |
| 06009544034858 | K192651 | 000 |
| 06009544039211 | K192651 | 000 |
| 06009544034728 | K192651 | 000 |
| 06009544034711 | K192651 | 000 |
| 06009544034704 | K192651 | 000 |
| 06009544034698 | K192651 | 000 |
| 06009544034681 | K192651 | 000 |
| 06009544034674 | K192651 | 000 |
| 06009544034667 | K192651 | 000 |
| 06009544034650 | K192651 | 000 |
| 06009544039266 | K192651 | 000 |
| 06009544039259 | K192651 | 000 |
| 06009544039235 | K192651 | 000 |
| 06009544039228 | K192651 | 000 |
| 06009544034766 | K192651 | 000 |