# K233389: EK Digital Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: May 29, 2024 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 K894844 (1990). 198 ancestors in all.
No later device cites it as a predicate yet.
0 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123627: ET Smartfit Abutment, Hiossen, Inc. (2013) Summary page 5.
- K162390: ET Hybrid Abutment, Hiossen, Inc. (2017) Summary page 5.

## Indications for use
EK DIGITAL ABUTMENTS are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Source page: https://510kreport.com/device/K233389
Methodology: https://510kreport.com/methodology