# K193084: TIB Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Oct 27, 2020 after 357 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: 14 generations back to K925765 (1993). 273 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 277 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180899: Universal Base Abutment, Nobel Biocare AB (2018) Summary page 4.
- K181359: InterActive SMARTBase Abutments, Implant Direct Sybron Manufacturing, LLC (2018) Summary page 4.
- K111421: Sirona Dental Cad/Cam System, Sirona Dental Systems GmbH (2012) Summary page 4.
- K163634: External Hex Implants, Southern Implants (Pty), Ltd. (2017) Summary page 4.
- K130991: Nexxzr (TM)T and Nexxzr (TM)S, Sagemax Bioceramics, Inc. (2014) Summary page 4.
- K130436: Multilink Hybrid Abutment Cement, Ivoclar Vivadent, AG (2013) Summary page 4.
- K151455: 3Shape Abutment Designer Software, 3Shape A/S (2016) Summary page 4.

## Most influential descendants
- K230873: Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments (2023), 0 descendants of its own
- K222469: TIB Abutments (2023), 0 descendants of its own
- K222457: Provata Implant System (2023), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K193084
Methodology: https://510kreport.com/methodology