Medical Device Manufacturer · US , Fariless Hills , PA

Hiossen, Inc. - FDA 510(k) Cleared Devices

26 submissions · 26 cleared · Since 2009

Recent clearances: ET Healing Abutments, EK MULTI ANGLED 30 ABUTMENT, HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)

Total

Cleared

Denied

Hiossen, Inc. has 26 FDA 510(k) cleared dental devices. Based in Fariless Hills, US.

Latest FDA clearance: May 2026. Active since 2009.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by IZiel Healthcare as regulatory consultant.

Hiossen, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Hiossen, Inc.

26 devices

1-12 of 26

EK MULTI ANGLED 30 ABUTMENT

K251427 · NHA

Dental · 266d

Cleared Jan 08, 2025

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)

K241003 · NHA

Dental · 271d

Cleared Sep 13, 2024

EK D3.3 and Ultra Wide Implants

EK Implants and Abutments System

ET IV SA Dental Implants

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Jun 05, 2026

Hiossen, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Hiossen, Inc.

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