Hiossen, Inc. FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments510(k)May 14, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 14, 2026
EK MULTI ANGLED 30 ABUTMENT510(k)Jan 29, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 29, 2026
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)510(k)Jan 8, 2025Dental	Dental	510(k)Substantially Equivalent (Abbreviated)	Jan 8, 2025
EK D3.3 and Ultra Wide Implants510(k)Sep 13, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 13, 2024
EK Digital Abutments510(k)May 29, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 29, 2024
ET Abutment System510(k)Apr 28, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Apr 28, 2023
EK Implants and Abutments System510(k)Jan 7, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 7, 2022