Izenimplant Co., Ltd. FDA Approvals

0 new drug approvals and 8 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
ZENEX Implant System_Short (R-System)510(k)Mar 16, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 16, 2026
ZENEX Implant System_R-System510(k)Jan 8, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 8, 2026
ZENEX Implant System_Long510(k)Oct 30, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 30, 2024
Ti Link Abutment510(k)Jan 12, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 12, 2024
ZENEX Implant System_Short510(k)Dec 19, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 19, 2023
ZENEX FreeMilling & CCM Cast Abutment510(k)Aug 24, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 24, 2023
ZENEX Implant System_Narrow510(k)Jul 31, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 31, 2023
ZENEX Implant System510(k)Apr 13, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Apr 13, 2022