Not currently registered with FDA under this name
Hoowon Edi Co., Ltd.
Gimhae, South Korea. Named as applicant on 1 dental 510(k) clearance between 2024 and 2024. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12024–2024
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
510(k) clearances
Clearances on which FDA names Hoowon Edi Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 May 2024 | K231426 | 8plant Implant System | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: 8dent Inc. (1), Eclectic Co., Ltd. (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.