Izenimplant Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Izenimplant Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: ZENEX Implant System_Short (R-System), ZENEX Implant System_R-System, ZENEX Implant System_Long
8
Total
8
Cleared
0
Denied
Izenimplant Co., Ltd. has 8 FDA 510(k) cleared medical devices. Based in Pyeongtaek-Si, KR.
Latest FDA clearance: Mar 2026. Active since 2022. Primary specialty: Dental.
Browse the FDA 510(k) cleared devices submitted by Izenimplant Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Withus Group, Inc. and KMC, Inc..
FDA 510(k) Regulatory Record - Izenimplant Co., Ltd.
8 devices
Cleared
Mar 16, 2026
ZENEX Implant System_Short (R-System)
Dental
167d
Cleared
Jan 08, 2026
ZENEX Implant System_R-System
Dental
146d
Cleared
Oct 30, 2024
ZENEX Implant System_Long
Dental
244d
Cleared
Jan 12, 2024
Ti Link Abutment
Dental
175d
Cleared
Dec 19, 2023
ZENEX Implant System_Short
Dental
83d
Cleared
Aug 24, 2023
ZENEX FreeMilling & CCM Cast Abutment
Dental
86d
Cleared
Jul 31, 2023
ZENEX Implant System_Narrow
Dental
146d
Cleared
Apr 13, 2022
ZENEX Implant System
Dental
366d