The following data is part of a premarket notification filed by Southern Implants (pty) Ltd with the FDA for Southern Implants Peek Abutments.
| Device ID | K191250 |
| 510k Number | K191250 |
| Device Name: | Southern Implants PEEK Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Southern Implants (Pty) Ltd 1 Albert Road Irene, ZA 0062 |
| Contact | Lauranda Breytenbach |
| Correspondent | Lauranda 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 | 2019-05-09 |
| Decision Date | 2019-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009544025443 | K191250 | 000 |
| 06009544030478 | K191250 | 000 |
| 06009544030461 | K191250 | 000 |
| 06009544025399 | K191250 | 000 |
| 06009544025382 | K191250 | 000 |
| 06009544025375 | K191250 | 000 |
| 06009544025276 | K191250 | 000 |