Data / Medical devices / Italy / Trident SRL
Trident SRL: FDA-registered device maker in Castenedolo Brescia, Italy, 6 510(k) clearances
Trident SRL is registered with the FDA (registration 3012649815) in Castenedolo Brescia, Italy. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 10, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012649815
- Address
- Via Artigiani 4, Castenedolo Brescia, Italy, 25014
- Owner or operator
- Trident SRL (10051619)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 12, 2016
- Registered through
- 2026
- Brand names listed
- BOOM sensor, BOOM sensor size 2, Blu, Blu size 2, I-View Gold, I-View Gold size 2, I-View Sensor, I-View Silver and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 10, 2023 | K222666 | X-View 3D Pan/X-View 2D Pan | OAS | Substantially Equivalent | Trident S.R.L | accessdata.fda.gov |
| April 23, 2021 | K210312 | PlutoX Digital Intraoral X-Ray Imaging System | MUH | Substantially Equivalent | Iray Technology Taicang , Ltd. | accessdata.fda.gov |
| April 15, 2020 | K200625 | I-View Gold and Imagen Gold Dental Sensors | MUH | Substantially Equivalent | Trident S.R.L | accessdata.fda.gov |
| September 13, 2018 | K182206 | RiX70 DC | EHD | Substantially Equivalent | Trident S.R.L | accessdata.fda.gov |
| November 4, 2016 | K162619 | I View and Imagen Sensor | MUH | Substantially Equivalent | Trident S.R.L | accessdata.fda.gov |
| March 10, 2016 | K160386 | ReadeR, VieweR, QuickScan PSP | MUH | Substantially Equivalent | Trident S.R.L | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of X-Ray, Tomography, Computed, Dental
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of Unit, X-Ray, Extraoral With Timer
Updated July 10, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.