Data / Medical devices / Abutment, Implant, Dental, Endosseous / South Korea
FDA-registered makers of Abutment, Implant, Dental, Endosseous in South Korea: 44 establishments
44 establishments in South Korea are registered with the FDA to make Abutment, Implant, Dental, Endosseous (product code NHA). 28 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Abutment, Implant, Dental, Endosseous
- Product code
- NHA
- Country
- South Korea
Makers of Abutment, Implant, Dental, Endosseous in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 21 | January 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Haeundae-gu Busan, South Korea | Complaint file establishment, Contract manufacturer, Manufacturer | 16 | March 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Dentis Co., Ltd. | Daegu, South Korea | Manufacturer | 13 | July 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| TruAbutment Korea Co., Ltd. | Bucheon-si Gyeonggi, South Korea | Manufacturer | 13 | October 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dentium Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 11 | January 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| MegaGen Implant Co., Ltd. (Research Laboratories) | Daegu, South Korea | Specification developer | 9 | January 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Megagen Implant Co., Ltd. | Daegu, South Korea | Manufacturer | 9 | January 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| ARUM DENTISTRY Co., Ltd. | Yuseong-gu Daejeon, South Korea | Manufacturer | 6 | November 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| DIO Corporation | Haeundae-gu Busan, South Korea | Manufacturer | 5 | August 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Innobiosurg Co., Ltd. | Daejeon, South Korea | Manufacturer | 5 | August 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Cowellmedi Co., Ltd. | Busan, South Korea | Manufacturer | 4 | September 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ossvis Co., Ltd. | Anyang-si Gyeonggi, South Korea | Manufacturer | 4 | December 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Simda Co.,ltd. | Busan, South Korea | Manufacturer | 3 | December 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Geomedi Co., Ltd. | Uiwang-si, Gyeonggi, South Korea | Contract manufacturer, Exporter to the US, Manufacturer | 2 | June 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Izenimplant Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 2 | January 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Izenimplant Co., Ltd. | Pyeongtaek-si Gyeonggi, South Korea | Manufacturer | 2 | January 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Neobiotech Co., Ltd. | Wonju-si Gangwon, South Korea | Manufacturer | 2 | April 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| SMD Dental Laboratory | Heungdeok-gu Cheongju-si Chungbuk, South Korea | Manufacturer | 2 | February 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shinhung MST Co., Ltd. | Wonju Si Gangwon, South Korea | Manufacturer | 2 | February 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| WARANTEC Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 2 | October 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| ACH Medical Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 1 | August 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Allonus Tech Co., Ltd. | Yangsan-si Gyeongnam, South Korea | Manufacturer | 1 | December 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Daekwang I.D.M | Seoul, South Korea | Manufacturer | 1 | August 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Eclectic Inc. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 1 | October 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| KJ Meditech Co., Ltd. | Gwangju, South Korea | Contract manufacturer, Manufacturer | 1 | August 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Oneday Biotech Co., Ltd. | Daegu, South Korea | Manufacturer | 1 | February 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Surgident Co., Ltd. | Dong-gu Daegu, South Korea | Manufacturer | 1 | May 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Zeros Co., Ltd. | Gimhae-si Gyeongnam, South Korea | Manufacturer | 1 | July 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| 8dent Inc. | Gimhae-si Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotem Co., Ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CSM Implant | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cybermed Inc. | Daejeon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denq Co., Ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIMPLO Ltd. | Yeonje-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evidence Implant Inc. | Daegu, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| F&B Technology Co., Ltd. | Sasang-ku Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Highness Co.,ltd. | Gyeongsangbuk-do Gyeongbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Idis Co., Ltd. | Bucheon-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimecca Co Ltd | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| POINTIMPLANT Co., Ltd | Busan, South Korea | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sewon Medix, Inc. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Snucone Co., Ltd. | Dalseo-gu Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| T. Strong Inc. | Gimhae-si Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unidental.co.kr | Gwangmyeong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.