# K093562: Endosseous Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants, Inc.
- Decided: Oct 14, 2010 after 330 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: 3 generations back to K925771 (1993). 13 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970499: Branemark System Zygomaticus Fixture System, Nobel Biocare Uas, Inc. (1997) Summary page 1.
- K070182: Zygoma Implant (Immediate Function), Nobel Biocare AB (2007) Summary page 1.

## Most influential descendants
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own
- K173343: Zygomatic Implant System (2018), 2 descendants of its own
- K210356: Noris Medical Dental Implants System (2022), 1 descendant of its own
- K192651: ZAGA Zygomatic System (2020), 1 descendant of its own
- K153064: Blue Sky Bio Zygomatic Implant System (2016), 1 descendant of its own

## Indications for use
The Zygomatic implant is 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.

Source page: https://510kreport.com/device/K093562
Methodology: https://510kreport.com/methodology