FDA.reportPublic FDA data

IZENIMPLANT CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30180972393018097239IZENIMPLANT CO., LTD.1N2026-01-011, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon Pyeongtaek-si Gyeonggi KR 17703

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2863001140172347K253334ZENEX Implant System_Short (R-System)DZE2026-03-16
2863001111267369K252585ZENEX Implant System_R-SystemDZE2026-01-08
2863001022711500K240560ZENEX Implant System_LongDZE2024-10-30
2863001540432989K233163ZENEX Implant System_ShortDZE2023-12-19
2863001757887141K232170Ti Link AbutmentNHA2024-01-12
2863001748831231K231557ZENEX FreeMilling & CCM Cast AbutmentNHA2023-08-24
2863001923386927K230630ZENEX Implant System_NarrowDZE2023-07-31
2863001242835240K211090ZENEX Implant SystemDZE2022-04-13
2863001767323141
2863001999954425

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE62026-03-16
NHA22024-01-12

PMN#

GUDID#

200 records. Showing 1-40. Next