# K231426: 8plant Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Hoowon Edi Co., Ltd.
- Decided: May 24, 2024 after 373 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: 16 generations back to K894595 (1990). 241 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 243 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.

## Most influential descendants
- K251605: DIMPLO Implant System (2025), 0 descendants of its own

## Indications for use
8plant 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. Implant bodies with a diameter of 5mm or more are intended to be used in the molar region.

Source page: https://510kreport.com/device/K231426
Methodology: https://510kreport.com/methodology