# K203360: EK Implants and Abutments System

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Jan 7, 2022 after 417 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). 258 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140934: Hiossen Implant System, Hiossen, Inc. (2014) Summary page 4.
- K151626: ET III Bio-SA Fixture System, Hiossen, Inc. (2016) Summary page 4.
- K182091: Osstem Abutment System, Osstem Implant Co., Ltd. (2019) Summary page 4.
- K161689: OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. (2017) Summary page 4.
- K140507: Hiossen Prosthetic System, Osstem Implant Co., Ltd. (2014) Summary page 4.
- K110308: Prosthetic System, Osstem Implant Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K221866: S-Plant Dental Implant System (2024), 2 descendants of its own
- K253372: ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments (2026), 0 descendants of its own
- K251427: EK Multi Angled 30 Abutment (2026), 0 descendants of its own
- K243731: HEXIM Implant; Samwon General Abutments (2025), 0 descendants of its own
- K240232: EK D3.3 and Ultra Wide Implants (2024), 0 descendants of its own

## Indications for use
The EK Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is indicated for delayed loading. Ultra wide versions are indicated for use in the molar region only. The EK Dental Implants (Ø3.5mm) are made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The EK Dental Implants (Ø3.5mm) are indicated for use in mandibular and maxillary lateral and central incisor, 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. The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.

Source page: https://510kreport.com/device/K203360
Methodology: https://510kreport.com/methodology