# K252585: ZENEX Implant System_R-System

- Pathway: 510(k) (Traditional)
- Applicant: Izenimplant Co., Ltd.
- Decided: Jan 8, 2026 after 146 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: 19 generations back to K960026 (1996). 420 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 422 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211090: ZENEX Implant System, Izenimplant Co., Ltd. (2022) Summary page 5.
- K181138: IS-III active System, Neobiotech Co., Ltd. (2018) Summary page 5.
- K203240: AccelX Abutments, Integrated Dental Systems, LLC (2021) Summary page 5.
- K210826: Healing Abutment, Cover Screw, Megagen Implant Co., Ltd. (2022) Summary page 5.
- K231557: ZENEX FreeMilling & CCM Cast Abutment, Izenimplant Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- K253334: ZENEX Implant System_Short (R-System) (2026), 0 descendants of its own

## Indications for use
ZENEX Implant System_R-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/K252585
Methodology: https://510kreport.com/methodology