# K253334: ZENEX Implant System_Short (R-System)

- Pathway: 510(k) (Traditional)
- Applicant: Izenimplant Co., Ltd.
- Decided: Mar 16, 2026 after 167 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: 20 generations back to K960026 (1996). 422 ancestors in all.
No later device cites it as a predicate yet.
0 of 423 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233163: ZENEX Implant System_Short, Izenimplant Co., Ltd. (2023) Summary page 5.
- K252585: ZENEX Implant System_R-System, Izenimplant Co., Ltd. (2026). Cleared while this submission was under review Summary page 5.
- (no number) ZENEX Implant System by Izenimplant Co., Ltd.: named in the summary without a submission number

## Indications for use
ZENEX Implant SystemShort(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. Short and Wide implants must be splinted to adjacent implants in areas of poor bone quality or high occlusal forces.

Source page: https://510kreport.com/device/K253334
Methodology: https://510kreport.com/methodology