# K173343: Zygomatic Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Feb 27, 2018 after 126 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K960026 (1996). 305 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 308 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093562: Endosseous Dental Implant, Southern Implants, Inc. (2010) Summary page 4.
- K151909: Noris Medical Zygomatic Dental Implant System, Noris Medical, Ltd. (2016) Summary page 4.
- K070841: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 4.
- K053478: Endosseous Dental Implant System, Northern Implants, LLC (2006) Summary page 4.
- K141777: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2015) Summary page 4.

## Most influential descendants
- K192651: ZAGA Zygomatic System (2020), 1 descendant of its own
- K222497: Zaga Zygomatic System (2022), 0 descendants of its own

## Indications for use
Southern Implants Zygomatic System Standard implants, Zygan (narrow apex) implants, and Oncology implants are intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K173343
Methodology: https://510kreport.com/methodology