Not currently registered with FDA under this name
Intai Technology Corp.
Taichung, Taiwan. Named as applicant on 1 dental 510(k) clearance between 2013 and 2013. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12013–2013
- Markets registered in
- 349 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Intai Technology Corp. 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 | Intai Technology Corp. | 1 clearances | 2013–2013 | Below |
| Colombia | INVIMA | Manufacturer | INTAI TECHNOLOGY CORP. | 39 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | INTAI Technology Corp. | 10 | — | 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 Intai Technology Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 May 2013 | K122804 | ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Intai Technology Corp. Implants Business Unit (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.