Data / Medical devices / X-Ray, Tomography, Computed, Dental / South Korea
FDA-registered makers of X-Ray, Tomography, Computed, Dental in South Korea: 10 establishments
10 establishments in South Korea are registered with the FDA to make X-Ray, Tomography, Computed, Dental (product code OAS). 10 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
- X-Ray, Tomography, Computed, Dental
- Product code
- OAS
- Country
- South Korea
Makers of X-Ray, Tomography, Computed, Dental in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Vatech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 13 | March 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ray Co., Ltd | Yongin-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 10 | April 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Dentium Co.,ltd(ict Branch) | Suwon Gyeonggi, South Korea | Manufacturer | 3 | December 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Dentium Co.,ltd(ict Branch) | Yongin Gyeonggi, South Korea | Manufacturer | 3 | December 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Genoray Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 3 | October 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| HDX Will Corp. | Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South Korea | Manufacturer | 3 | December 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 3 | September 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co.,ltd. | Yeonsu-gu Incheon, South Korea | Manufacturer | 3 | September 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| MegaGen Implant Co., Ltd. (Research Laboratories) | Daegu, South Korea | Specification developer | 1 | December 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Megagen Implant Co., Ltd. | Daegu, South Korea | Manufacturer | 1 | December 6, 2022 | 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.