# Izenimplant Co., Ltd.

- Location (FDA's records): Pyeongtaek-Si, KR
- FDA decisions: 8 (2022–2026): 8 510(k) clearances
- Product codes: DZE (6), NHA (2)
- 510(k) review time since 2016: median 157 days, against 208 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 16 (5 its own); citations of its devices by later devices: 9 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Osstem Implant Co., Ltd.: 4 (https://510kreport.com/company/osstem-implant)
- Dio Corporation: 2 (https://510kreport.com/company/dio)
- Neobiotech Co., Ltd.: 2 (https://510kreport.com/company/neobiotech)
- Dentis Co., Ltd.: 1 (https://510kreport.com/company/dentis)
- Integrated Dental Systems, LLC: 1 (https://510kreport.com/company/integrated-dental-systems)
- Megagen Implant Co., Ltd.: 1 (https://510kreport.com/company/megagen-implant)

## Firms that cite its devices most
- MBA Biotech Co., Ltd.: 1 (https://510kreport.com/company/mba-biotech)
- Hoowon Edi Co., Ltd.: 1 (https://510kreport.com/company/hoowon-edi)
- Dentis Co., Ltd.: 1 (https://510kreport.com/company/dentis)
- Oneday Biotech Co., Ltd.: 1 (https://510kreport.com/company/oneday-biotech)

## Its most-cited devices
- K211090: ZENEX Implant System (2022), cited by 6
- K231557: ZENEX FreeMilling & CCM Cast Abutment (2023), cited by 1
- K252585: ZENEX Implant System_R-System (2026), cited by 1
- K233163: ZENEX Implant System_Short (2023), cited by 1

## Recent decisions
- K253334: ZENEX Implant System_Short (R-System) (Mar 16, 2026)
- K252585: ZENEX Implant System_R-System (Jan 8, 2026)
- K240560: ZENEX Implant System_Long (Oct 30, 2024)
- K232170: Ti Link Abutment (Jan 12, 2024)
- K233163: ZENEX Implant System_Short (Dec 19, 2023)
- K231557: ZENEX FreeMilling & CCM Cast Abutment (Aug 24, 2023)
- K230630: ZENEX Implant System_Narrow (Jul 31, 2023)
- K211090: ZENEX Implant System (Apr 13, 2022)

Source page: https://510kreport.com/company/izenimplant