Data / Medical devices / Denmark / 3shape Trios A/S
3shape Trios A/S: FDA-registered device maker in copenhagen Hovedstaden, Denmark, 3 510(k) clearances
3shape Trios A/S is registered with the FDA (registration 3009560013) in copenhagen Hovedstaden, Denmark. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009560013
- Address
- Holmens Kanal 7, copenhagen Hovedstaden, Denmark, 1060
- Owner or operator
- 3Shape Trios (10040244)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 23, 2012
- Registered through
- 2026
- Brand names listed
- 3Shape F8, L1P-1F, S1P-2 scanning tip, TRIOS 3 Wireless, TRIOS 4, TRIOS Patient Monitoring, Trios 3, Trios 5 (L1P-1F) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dental Image Analyzer, In-Office | SHQ | 2 | Specification developer | accessdata.fda.gov |
| Light-Induced Fluorescence Caries Detector | NBL | 2 | Manufacturer | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 10, 2026 | K260082 | TRIOS Dx (R1) | SHQ | Substantially Equivalent | 3Shape TRIOS A/S | accessdata.fda.gov |
| April 4, 2025 | K242103 | TRIOS Ready Tip | NBL | Substantially Equivalent | 3Shape TRIOS A/S | accessdata.fda.gov |
| September 16, 2022 | K221249 | L1P-1F (TRIOS 5) | NBL | Substantially Equivalent | 3Shape TRIOS A/S | accessdata.fda.gov |
Compare with other makers
- All makers of Light-Induced Fluorescence Caries Detector
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Updated April 10, 2026. 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.