Not currently registered with FDA under this name
Saeyang Microtech Co., Ltd.
Daegu, South Korea. Named as applicant on 4 dental 510(k) clearances between 2013 and 2022. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42013–2022
- Markets registered in
- 616 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Saeyang Microtech Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Saeyang Microtech Co., Ltd. | 4 clearances | 2013–2022 | Below |
| Taiwan | TFDA | Manufacturer | SAEYANG MICROTECH CO., LTD.SAEYANG MICROTECH. CO., LTD. | 11 | 2008–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | SAEYANG MICROTECH Co., Ltd.Saeyang Microtech Co Ltd | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Saeyang Microtech Co Ltd | 1 | 2022–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SAEYANG MICROTECH CO., LTD | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SAEYANG MICROTECH CO., LTD. | 1 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Saeyang Microtech Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Sep 2022 | K213897 | Pro M Class | EKX Ac-Powered Direct Drive Handpiece |
| 24 Apr 2015 | K141482 | KI-20 | EBW Handpiece and Cord Foot Controller |
| 16 Aug 2013 | K123608 | ENDO E CLASS | EBW Handpiece and Cord Foot Controller |
| 16 Aug 2013 | K123582 | ENDO A CLASS | EKX Ac-Powered Direct Drive Handpiece |
Some of these clearances are listed with FDA today by another company: SAEYANG Co.,Ltd 韩国（株）世洋 (4), Coltene/Whaledent AG (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.