Data / Medical devices / Unit, Operative Dental / South Korea
FDA-registered makers of Unit, Operative Dental in South Korea: 11 establishments
11 establishments in South Korea are registered with the FDA to make Unit, Operative Dental (product code EIA). 9 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Unit, Operative Dental
- Product code
- EIA
- Country
- South Korea
Makers of Unit, Operative Dental 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 | 3 | July 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co.,ltd. | Yeonsu-gu Incheon, South Korea | Manufacturer | 3 | July 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| MegaGen Implant Co., Ltd. (Secheon 2nd factory) | Daegu, South Korea | Manufacturer | 2 | March 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shinhung Co. Ltd. | Ansan-si Gyeonggi, South Korea | Manufacturer | 2 | April 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Aiobio Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | July 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| DXM Co., Ltd. | Jeonnam-Gwangju Special Metropolitan City, South Korea | Manufacturer | 1 | April 20, 2004 | 0 | 0 | 0 | api.fda.gov |
| Hallim Point Implant Co., Ltd | SIHEUNG-SI Gyeonggi, South Korea | Manufacturer | 1 | February 25, 2011 | 0 | 0 | 0 | api.fda.gov |
| Mgnewton Ltd. | Gyengsan-si Gyeongbuk, South Korea | Manufacturer | 1 | May 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Winus Technology Co., Ltd. | Gun Po Si Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 1 | March 23, 2004 | 0 | 0 | 0 | api.fda.gov |
| Dentis Medical Division | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentis Medical Division | Dong-gu Daegu, 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.