Data / Medical devices / Handpiece, Direct Drive, Ac-Powered / South Korea
FDA-registered makers of Handpiece, Direct Drive, Ac-Powered in South Korea: 8 establishments
8 establishments in South Korea are registered with the FDA to make Handpiece, Direct Drive, Ac-Powered (product code EKX). 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
- Handpiece, Direct Drive, Ac-Powered
- Product code
- EKX
- Country
- South Korea
Makers of Handpiece, Direct Drive, Ac-Powered in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Micro-Nx Co., Ltd. | Dong-gu Daegu, South Korea | Manufacturer | 2 | November 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| Saeshin Precision Co., Ltd. | Daegu, South Korea | Manufacturer | 2 | June 29, 2015 | 0 | 0 | 0 | api.fda.gov |
| Saeyang Co., Ltd. | DALSEO-GU Daegu, South Korea | Manufacturer | 2 | September 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Dentis Medical Division | Daegu, South Korea | Manufacturer | 1 | March 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Dentis Medical Division | Dong-gu Daegu, South Korea | Manufacturer | 1 | March 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| DMS Co., Ltd. | Wonju-si Gangwon, South Korea | Manufacturer | 1 | February 20, 2019 | 0 | 0 | 0 | api.fda.gov |
| GENOSS Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 1 | August 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| META SYSTEMS CO., LTD also doing business as S-Denti Co.,Ltd | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | September 21, 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.