Manufacturer registered with FDA
Trident SRL
Castenedolo, Italy. Lists 4 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 18
- 510(k) clearances
- 52016–2023
- Markets registered in
- 836 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Trident SRL 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 | Trident SRL | 5 clearances | 2016–2023 | Below |
| Saudi Arabia | SFDA | Manufacturer | Trident S.R.LTrident S.r.l. | 15 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | TRIDENT SRL.TRIDENT SRL | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Trident Srl | 5 | 2016–2016 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | TRIDENT S.R.LTRIDENT S.R.L. | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TRIDENT S.R.L. | 3 | 2019–2024 | Pure Global AI |
| Canada | Health Canada | Registration holder | TRIDENT S.R.L. | 2 | 2022–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TRIDENT S.R.L. | 1 | 2018–2018 | 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 Trident SRL currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | BluBlu size 2BOOM sensorBOOM sensor size 2I-View GoldI-View Gold size 2I-View SensorI-View SilverI-View Silver size 2Imaagen Sensor 5 moreImagen Sensor GoldImagen Sensor Gold size 2QuickScan PSPReadeRVieweR | 2016 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | — | 2018 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Imagen ScanTriScan | 2022 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | X-VIEW 3D PAN; X-VIEW 2D PAN | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Trident SRL as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Jul 2023 | K222666 | X-View 3D Pan/X-View 2D Pan | OAS Dental Computed Tomography X-Ray |
| 15 Apr 2020 | K200625 | I-View Gold and Imagen Gold Dental Sensors | MUH Digital Extraoral Source X-Ray System |
| 13 Sep 2018 | K182206 | RiX70 DC | EHD Extraoral with Timer X-Ray Unit |
| 4 Nov 2016 | K162619 | I View and Imagen Sensor | MUH Digital Extraoral Source X-Ray System |
| 10 Mar 2016 | K160386 | ReadeR, VieweR, QuickScan PSP | MUH Digital Extraoral Source X-Ray System |
Also lists devices cleared under other names
Trident SRL 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: Iray Technology Taicang , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Apr 2021 | K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang , Ltd. | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TRIDENT SRLFDA reg. 3012649815 | Castenedolo Brescia, Italy | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051619). 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.