Not currently registered with FDA under this name
Fona S.R.L
Assago, Italy. Named as applicant on 4 dental 510(k) clearances between 2016 and 2022. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42016–2022
- Markets registered in
- 518 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Fona S.R.L 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 | Fona S.R.L | 4 clearances | 2016–2022 | Below |
| Taiwan | TFDA | Manufacturer | FONA S.r.L.FONA S.r.l. · FONA S.R.L. | 7 | 2017–2019 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | FONA S.r.l.FONA S.r.L. | 6 | 2022–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | FONA S.R.L | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | FONA SRL | 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 Fona S.R.L as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Aug 2022 | K222274 | FONA XDC | EHD Extraoral with Timer X-Ray Unit |
| 2 Mar 2022 | K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | OAS Dental Computed Tomography X-Ray |
| 30 Aug 2021 | K212103 | StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 | MUH Digital Extraoral Source X-Ray System |
| 3 Nov 2016 | K161131 | FONA Pan/Ceph | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: XLINE S.r.l. (4), Beyes Dental Inc (2).
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.