# K222636: ET Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Apr 28, 2023 after 240 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K894595 (1990). 230 ancestors in all.
No later device cites it as a predicate yet.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182091: Osstem Abutment System, Osstem Implant Co., Ltd. (2019) Summary page 4.

## Indications for use
The ET Abutments are indicated for use with ET Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.

Source page: https://510kreport.com/device/K222636
Methodology: https://510kreport.com/methodology