# K112532: ET II Bio-SA Fixture System

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Aug 6, 2012 after 341 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). 96 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 107 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.
- K072363: Nanotite Prevail,Certain,Parellel Walled,Tapered,External Hex, Biomet 3i, Inc. (2008) Summary page 1.
- K073070: Dio Biotite-H Implant System, Dio Department Dsi, Inc. (2008) Summary page 1.

## 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
ETIII Bio-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 terminal or intermediate abutment support for fixed bridgework. ETIII Bio-SA Fixture System is for single and two stage surgical procedures. It is intended for delayed loading.

Source page: https://510kreport.com/device/K112532
Methodology: https://510kreport.com/methodology