# K183242: ET IV SA Dental Implants

- Pathway: 510(k) (Special)
- Applicant: Hiossen, Inc.
- Decided: May 21, 2019 after 181 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 ET IV SA Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide version is intended to be used in the molar region.

Source page: https://510kreport.com/device/K183242
Methodology: https://510kreport.com/methodology