Data / Medical devices / Implant, Endosseous, Orthodontic / South Korea
FDA-registered makers of Implant, Endosseous, Orthodontic in South Korea: 8 establishments
8 establishments in South Korea are registered with the FDA to make Implant, Endosseous, Orthodontic (product code OAT). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Implant, Endosseous, Orthodontic
- Product code
- OAT
- Country
- South Korea
Makers of Implant, Endosseous, Orthodontic in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biomaterials Korea Inc. | Hanam-si Gyeonggi, South Korea | Manufacturer | 4 | August 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Haeundae-gu Busan, South Korea | Manufacturer | 2 | December 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Dentos, Incorporated | Daegu, South Korea | Manufacturer | 1 | February 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| GNI Co., LTD | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 1 | August 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Seoul, South Korea | Manufacturer | 1 | February 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| MK Meditech | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | December 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 1 | March 25, 2011 | 0 | 0 | 0 | api.fda.gov |
| Osteonic Co., Ltd. | Seoul, South Korea | Manufacturer | 1 | October 15, 2021 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.