The following data is part of a premarket notification filed by Southern Implants (pty) Ltd with the FDA for Tib Abutment System.
| Device ID | K193084 |
| 510k Number | K193084 |
| Device Name: | TIB Abutment System |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-05 |
| Decision Date | 2020-10-27 |
| Summary: | summary |