# K191250: Southern Implants PEEK Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Dec 5, 2019 after 210 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K891615 (1989). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172160: Southern Implants PEEK Abutments, Southern Implants (Pty), Ltd. (2018) Summary page 4.

## Most influential descendants
- K222457: Provata Implant System (2023), 0 descendants of its own

## Indications for use
The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K191250
Methodology: https://510kreport.com/methodology