The following data is part of a premarket notification filed by Southern Implants (pty) Ltd with the FDA for Southern Implants Max Implant System.
| Device ID | K191054 |
| 510k Number | K191054 |
| Device Name: | Southern Implants MAX Implant 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 | 2019-04-19 |
| Decision Date | 2019-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009544037002 | K191054 | 000 |
| 06009544037026 | K191054 | 000 |
| 06009544037170 | K191054 | 000 |
| 06009544036913 | K191054 | 000 |
| 06009544036920 | K191054 | 000 |
| 06009544036937 | K191054 | 000 |
| 06009544036944 | K191054 | 000 |
| 06009544036951 | K191054 | 000 |
| 06009544036968 | K191054 | 000 |
| 06009544036982 | K191054 | 000 |
| 06009544036999 | K191054 | 000 |
| 06009544037019 | K191054 | 000 |