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IZENIMPLANT CO., LTD.

Korea, Republic · Hwaseong-Si Gyeonggi

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, Russia — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 2Class II 2Class III 0

plus 19 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 1 2Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States19 registration records, 8 510(k), 0 PMA

Manufacturer names merged into this page: IZENIMPLANT CO., LTD.

FDA 510(k) clearances by year

12022 · K211090

32023 · K233163

22024 · K240560

22026 · K253334

FDA listed device types

Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1Drill, Dental, Intraoral 1Accessories, Implant, Dental, Endosseous 1

Market	Identifier	Name	Class / date
US	K253334	ZENEX Implant System_Short (R-System)	2026-03-16
US	K252585	ZENEX Implant System_R-System	2026-01-08
US	K240560	ZENEX Implant System_Long	2024-10-30

IZENIMPLANT CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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