# K123471: Etii SA Fixture System

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Jul 5, 2013 after 234 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: 11 generations back to K894595 (1990). 34 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 49 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 1.
- K090237: HG II Fixture System, Hiossen, Inc. (2009) Summary page 1.
- K091678: HG II Short Fixture System, Osstem Implant Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K140934: Hiossen Implant System (2014), 13 descendants of its own
- 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

## Indications for use
ETII SA Fixture 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.

Source page: https://510kreport.com/device/K123471
Methodology: https://510kreport.com/methodology