# K153332: ETIII SA Fixture System (O3.2mm)

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Oct 27, 2016 after 343 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: 13 generations back to K894595 (1990). 124 ancestors in all.
No later device cites it as a predicate yet.
0 of 125 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.

## Indications for use
The ETIII SA Fixture System (©3.2mm) is 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.

Source page: https://510kreport.com/device/K153332
Methodology: https://510kreport.com/methodology