Data / Medical devices / Switzerland / Zetta25 AG
Zetta25 AG: FDA-registered device maker in Zurich, Switzerland, 5 510(k) clearances
Zetta25 AG is registered with the FDA (registration 3029904428) in Zurich, Switzerland. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3029904428
- Address
- Albisriederstrasse 253, Zurich, Switzerland, 8047
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Manufacturer
- First device listed
- February 28, 2006
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Manufacturer | accessdata.fda.gov |
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Light Transmission Caries Detector | NTK | 2 | Manufacturer | 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 | 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 |
|---|---|---|---|---|---|---|
| August 21, 2026 | K262127 | DS Core CBCT Anatomy | QIH | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| April 23, 2026 | K260785 | DS Core CBCT Anatomy | QIH | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| January 7, 2026 | K253009 | DS Core Detect | MYN | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| August 29, 2025 | K250771 | Primescan 2 | NTK | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| August 12, 2025 | K250755 | DS Core Diagnosis | QIH | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of Analyzer, Medical Image
- All makers of Light Transmission Caries Detector
- All makers of Light-Induced Fluorescence Caries Detector
Updated August 21, 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.