Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Passive Abutment | PA-EL-50 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544017967 |
| (unnamed) | CS-L-60 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544002925 |
| Tri-Nex | IA-LHS-50-13 | SOUTHERN IMPLANTS (PTY) LTD | DZE | 06009544009702 |
| Tri-Nex | IA-LH-50-13 | SOUTHERN IMPLANTS (PTY) LTD | DZE | 06009544009504 |
| (unnamed) | LOB-35-5 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544015536 |
| Tri-Nex | IA-LH-60-16 | SOUTHERN IMPLANTS (PTY) LTD | DZE | 06009544009566 |
| (unnamed) | TCA12-EL-60 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544021384 |
| (unnamed) | MCL-43-17D2 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544016557 |
| Tri-Nex | IA-LH-35-8 | SOUTHERN IMPLANTS (PTY) LTD | DZE | 06009544009429 |
| Tri-Nex | IA-LH-35-11.5 | SOUTHERN IMPLANTS (PTY) LTD | DZE | 06009544009399 |
| Tri-Nex | IA-LHS-43-15 | SOUTHERN IMPLANTS (PTY) LTD | DZE | 06009544009665 |
| (unnamed) | PA-NL-60 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544018346 |
| (unnamed) | LOB-60-1 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544015635 |
| (unnamed) | PA-EL-60P | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544018001 |
| (unnamed) | TC-EL-35-5 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544021797 |
| Tri-Nex Co-Axis™ | IA43-12D-13 | SOUTHERN IMPLANTS (PTY) LTD | DZE | 06009544009290 |
| Tri-Nex Co-Axis™ | IA43-12D-11.5 | SOUTHERN IMPLANTS (PTY) LTD | DZE | 06009544009283 |
| (unnamed) | TCA-EL-43 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544021520 |
| Tri-Nex | IA-LHS-35-11.5 | SOUTHERN IMPLANTS (PTY) LTD | DZE | 06009544009597 |
| Tri-Nex | IA-LH-50-8 | SOUTHERN IMPLANTS (PTY) LTD | DZE | 06009544009528 |
| (unnamed) | TCA24-EL-43 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544021445 |
| (unnamed) | PA-NL-50TC | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544018339 |
| (unnamed) | MCN-L-50-2 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544016724 |
| (unnamed) | LOB-60-5 | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544015659 |
| (unnamed) | PA-EL-50TC | SOUTHERN IMPLANTS (PTY) LTD | NHA | 06009544017981 |