Not currently registered with FDA under this name
Juvora, Ltd.
Thornton-Clevelys, United Kingdom. Named as applicant on 3 dental 510(k) clearances between 2014 and 2018. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32014–2018
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Juvora, 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 | Applicant | Juvora, Ltd. | 3 clearances | 2014–2018 | Below |
| European Union | EUDAMED | Manufacturer | Juvora Limited | 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 Juvora, Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Dec 2018 | K181331 | JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White | EBI Rebasing Repairing Relining Denture Resin |
| 13 Feb 2017 | K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORA | EBI Rebasing Repairing Relining Denture Resin |
| 23 Jan 2014 | K132725 | JUVORA DENTQAL DISC | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: Amann Girrbach AG (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.