# K251427: EK Multi Angled 30 Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Jan 29, 2026 after 266 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: 16 generations back to K894595 (1990). 261 ancestors in all.
No later device cites it as a predicate yet.
0 of 262 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203360: EK Implants and Abutments System, Hiossen, Inc. (2022) Summary page 5.
- K182091: Osstem Abutment System, Osstem Implant Co., Ltd. (2019) Summary page 5.
- K233194: TS Abutment System, Osstem Implant Co., Ltd. (2024) Summary page 5.

## Indications for use
The EK Dental Abutments are indicated for use with EK 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/K251427
Methodology: https://510kreport.com/methodology