# K222469: TIB Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Apr 17, 2023 after 244 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: 15 generations back to K925765 (1993). 274 ancestors in all.
No later device cites it as a predicate yet.
0 of 275 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193084: TIB Abutment System, Southern Implants (Pty), Ltd. (2020) Summary page 4.

## Indications for use
The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The intended use for the TiB narrow abutments used with the 03.0 mm External hex and 03.0 mm Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular lateral and central incisors.

Source page: https://510kreport.com/device/K222469
Methodology: https://510kreport.com/methodology