Manufacturer registered with FDA
SAEYANG Co.,Ltd 韩国（株）世洋
DALSEO-GU, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 629 registrations outside the US
- Establishments
- 1South Korea
Registered in 6 markets
Where regulators' registries name SAEYANG Co.,Ltd 韩国（株）世洋 as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | SAEYANG Co.,Ltd 韩国（株）世洋 | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | SAEYANG CO.,LTD. | 17 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SAEYANG CO., LTD | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Saeyang Co., Ltd. | 4 | 2023–2026 | Pure Global AI |
| China | NMPA | Registration holder | SAEYANG Co.,Ltd 韩国（株）世洋韩国（株）世洋SAEYANG Co., Ltd | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SAEYANG CO., LTD | 2 | — | 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
Devices listed with FDA
What SAEYANG Co.,Ltd 韩国（株）世洋 currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | Endo E ClassKi-20 | 2022 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | CanalPro CL2Endo A ClassPRO M CLASS | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
SAEYANG Co.,Ltd 韩国（株）世洋 lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Saeyang Microtech Co., Ltd. (4).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Sep 2022 | K213897 | Pro M Class | Saeyang Microtech Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 24 Apr 2015 | K141482 | KI-20 | Saeyang Microtech Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 16 Aug 2013 | K123608 | ENDO E CLASS | Saeyang Microtech Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 16 Aug 2013 | K123582 | ENDO A CLASS | Saeyang Microtech Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SAEYANG CO., LTD.FDA reg. 3010551934 | DALSEO-GU Daegu, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086948). 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.