Manufacturer registered with FDA
XLINE S.r.l.
Assago, Italy. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 22
- 510(k) clearances
- 0as applicant
- Markets registered in
- 45 registrations outside the US
- Establishments
- 1Italy
Registered in 4 markets
Where regulators' registries name XLINE 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 | Manufacturer | XLINE S.r.l. | 3 device types | — | Below |
| Serbia | ALIMS | Manufacturer | XLINE S.R.L. | 3 | 2025–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | XLINE S.r.l. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | XLINE S.R.L. | 1 | 2024–2024 | 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
Devices listed with FDA
What XLINE S.r.l. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | FONA XDCIntraOs 70IntraOs DGPantOs 16 xpPantOs 16 xp CephPantOs DG xpVario DG | 2019 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | FONA ART PlusFONA ART Plus CFONA XPan DGFONA XPan DG PlusPantOs 16 xpPantOs 16 xp CephPantOs DG xpStarX PRO-1StarX PRO-2StarX-1 1 moreStarX-2 | 2019 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | Stellaris 2DStellaris 2D CephStellaris 3DStellaris 3D Ceph | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
XLINE S.r.l. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Fona S.R.L (4), Blue X Imaging Srl (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Aug 2022 | K222274 | FONA XDC | Fona S.R.L | EHD Extraoral with Timer X-Ray Unit |
| 2 Mar 2022 | K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | Fona S.R.L | OAS Dental Computed Tomography X-Ray |
| 30 Aug 2021 | K212103 | StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 | Fona S.R.L | MUH Digital Extraoral Source X-Ray System |
| 3 Nov 2016 | K161131 | FONA Pan/Ceph | Fona S.R.L | MUH Digital Extraoral Source X-Ray System |
| 11 Sep 2003 | K031801 | PANTOS, MODELS: PANTOS 16, AND PANTOS DG | Blue X Imaging Srl | MUH Digital Extraoral Source X-Ray System |
| 8 Jul 2003 | K031118 | INTRAOS 70 | Blue X Imaging Srl | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| XLINE SRLFDA reg. 3003528079 | ASSAGO Milano, Italy | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10061120). 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.