Data / Medical devices / South Korea / Izenimplant Co., Ltd.
Izenimplant Co., Ltd.: FDA-registered device maker in Pyeongtaek-si Gyeonggi, South Korea, 8 510(k) clearances
Izenimplant Co., Ltd. is registered with the FDA (registration 3018097239) in Pyeongtaek-si Gyeonggi, South Korea. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 16, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018097239
- Address
- 1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si Gyeonggi, South Korea, 17703
- Owner or operator
- Izenimplant Co., Ltd. (10080021)
- Roles
- Manufacturer
- First device listed
- January 7, 2021
- Registered through
- 2026
- Brand names listed
- 1.2 Hex Angled Driver for Ratchet (Model: HEADR1215, HEADR1220, HEADR1225), 1.2 Hex Angled Machine Screw Driver (Model: HEADM1215, HEADM1220), 1.2 Hex Driver for Ratchet (Model: HEDR1207), 1.2 Hex Driver for Ratchet (Model: HEDR1210, HEDR1215, HEDR1225), 1.2 Hex Lab Driver (Model: HEDR1207, HELD1225), 1.2 Hex Machine Screw Driver (Model: HEDM1210, HEDM1215), 1.25 Hex Driver for Ratchet (Model: HEDR12510, HEDR12515, HEDR12525), Abutment Remover (Model: ARRM18) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 16, 2026 | K253334 | ZENEX Implant System_Short (R-System) | DZE | Substantially Equivalent | Izenimplant Co., Ltd. | accessdata.fda.gov |
| January 8, 2026 | K252585 | ZENEX Implant System_R-System | DZE | Substantially Equivalent | Izenimplant Co., Ltd. | accessdata.fda.gov |
| October 30, 2024 | K240560 | ZENEX Implant System_Long | DZE | Substantially Equivalent | Izenimplant Co., Ltd. | accessdata.fda.gov |
| January 12, 2024 | K232170 | Ti Link Abutment | NHA | Substantially Equivalent | Izenimplant Co., Ltd. | accessdata.fda.gov |
| December 19, 2023 | K233163 | ZENEX Implant System_Short | DZE | Substantially Equivalent | Izenimplant Co., Ltd. | accessdata.fda.gov |
| August 24, 2023 | K231557 | ZENEX FreeMilling & CCM Cast Abutment | NHA | Substantially Equivalent | Izenimplant Co., Ltd. | accessdata.fda.gov |
| July 31, 2023 | K230630 | ZENEX Implant System_Narrow | DZE | Substantially Equivalent | Izenimplant Co., Ltd. | accessdata.fda.gov |
| April 13, 2022 | K211090 | ZENEX Implant System | DZE | Substantially Equivalent | Izenimplant Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Drill, Dental, Intraoral
Updated March 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.