Manufacturer registered with FDA
Chiyewon Co., Ltd.
Guri-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 12015–2015
- Markets registered in
- 11229 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Chiyewon 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 | Manufacturer | Chiyewon Co., Ltd. | 1 clearances | 2015–2015 | Below |
| European Union | EUDAMED | Manufacturer | Chiyewon Co., LTD. | 212 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Chiyewon Co., LtdCHIYEWON Co. Ltd · Chiyewon | 4 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Chiyewon Co., Ltd. | 3 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | CHIYEWON Co., Ltd. | 3 | 2024–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Chiyewon Co Ltd | 2 | 2024–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | CHIYEWON CO LTD | 1 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Chiyewon Co., Ltd. | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Chiyewon Co., Ltd. | 1 | 2025–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CHIYEWON Co., Ltd. | 1 | 2023–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Chiyewon Co., Ltd. | 1 | 2014–2014 | 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 Chiyewon Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | — | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CHIYEWON CO., LTD.FDA reg. 3011802717 | Guri-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049595). 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.