# K211090: ZENEX Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Izenimplant Co., Ltd.
- Decided: Apr 13, 2022 after 366 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: 15 generations back to K894595 (1990). 240 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161604: OSSTEM Implant System, Osstem Implant Co., Ltd. (2016) Summary page 4.
- K182091: Osstem Abutment System, Osstem Implant Co., Ltd. (2019) Summary page 4.
- K181138: IS-III active System, Neobiotech Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K252585: ZENEX Implant System_R-System (2026), 1 descendant of its own
- K231426: 8plant Implant System (2024), 1 descendant of its own
- K231753: Oneday Implant Abutment (2024), 1 descendant of its own
- K253334: ZENEX Implant System_Short (R-System) (2026), 0 descendants of its own
- K251605: DIMPLO Implant System (2025), 0 descendants of its own

## Indications for use
ZENEX Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region

Source page: https://510kreport.com/device/K211090
Methodology: https://510kreport.com/methodology