Not currently registered with FDA under this name
Ebi, Inc.
Gyeongsan-Si, South Korea. Named as applicant on 4 dental 510(k) clearances between 2008 and 2020. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42008–2020
- Markets registered in
- 26 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Ebi, Inc. 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 | Ebi, Inc. | 4 clearances | 2008–2020 | Below |
| Taiwan | TFDA | Manufacturer | EBI INC. | 6 | 2008–2014 | 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
510(k) clearances
Clearances on which FDA names Ebi, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Jan 2020 | K190837 | Internal Hex Implant System | DZE Root-Form Endosseous Implant |
| 31 Aug 2017 | K170031 | Internal Octa Implant System | DZE Root-Form Endosseous Implant |
| 27 Mar 2015 | K142426 | EBI External Implant System | DZE Root-Form Endosseous Implant |
| 28 Feb 2008 | K073116 | EBI INTERNAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Evidence Implant Inc. (4).
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.