Not currently registered with FDA under this name
Envisiontec GmbH
Gladbeck, Germany. Named as applicant on 3 dental 510(k) clearances between 2021 and 2021. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32021–2021
- Markets registered in
- 620 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Envisiontec GmbH 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 | Envisiontec GmbH | 3 clearances | 2021–2021 | Below |
| European Union | EUDAMED | Manufacturer | EnvisionTEC GmbH | 9 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | ENVISIONTEC GMBH | 5 | 2020–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ENVISIONTEC GMBHenvisionTEC GmbH | 3 | 2012–2021 | Pure Global AI |
| Australia | TGA | Manufacturer | EnvisionTEC GmbH | 2 | 2023–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | EnvisionTEC GmbH | 1 | — | 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 Envisiontec GmbH as the applicant.
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.