# K140934: Hiossen Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Nov 12, 2014 after 215 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: 12 generations back to K894595 (1990). 123 ancestors in all.
13 later devices descend from it; 6 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101096: HT Iii SA Fixture System, Hiossen, Inc. (2010) Summary page 4.
- K123471: Etii SA Fixture System, Hiossen, Inc. (2013) Summary page 4.
- K103537: ET Iii SA Ultra Wide System, Hiossen, Inc. (2011) Summary page 4.
- K121585: TS Implant System, Osstem Implant Co., Ltd. (2013) Summary page 4.
- K083633: HS II Short Fixture System, Osstem Implant Co., Ltd. (2009) Summary page 4.
- K120847: ET/SS Implant System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 4.

## Most influential descendants
- K151626: ET III Bio-SA Fixture System (2016), 9 descendants of its own
- K203360: EK Implants and Abutments System (2022), 7 descendants of its own
- 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

## Indications for use
The HIOSSEN 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. ETIII SA Ultra Wide Fixture is intended to be used in the molar region.

Source page: https://510kreport.com/device/K140934
Methodology: https://510kreport.com/methodology