# K151626: ET III Bio-SA Fixture System

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Jul 21, 2016 after 400 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894595 (1990). 150 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112532: ET II Bio-SA Fixture System, Hiossen, Inc. (2012) Summary page 4.
- K140934: Hiossen Implant System, Hiossen, Inc. (2014) Summary page 4.
- K053088: Slactive Implants, Institut Straumann AG (2006) Summary page 4.

## Most influential descendants
- 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
- K243731: HEXIM Implant; Samwon General Abutments (2025), 0 descendants of its own

## Recalls of this device
- Apr 6, 2023 · Class II · Z-1604-2023: Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm

## 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. The 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/K151626
Methodology: https://510kreport.com/methodology