Data / Medical devices / Switzerland / Z-Systems AG
Z-Systems AG: FDA-registered device maker in Oensingen Solothurn, Switzerland, 8 510(k) clearances
Z-Systems AG is registered with the FDA (registration 3006948427) in Oensingen Solothurn, Switzerland. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 25, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006948427
- Address
- Werkhofstrasse 5, Oensingen Solothurn, Switzerland, 4702
- Owner or operator
- Z-SYSTEMS AG (10024995)
- Roles
- Manufacturer
- First device listed
- December 31, 2012
- Registered through
- 2027
- Brand names listed
- Dental Implant Accessories, ST-Z5, Z5-BL, Z5-TL, Z5c, Z5m, Z5m lblc, Z5m(t) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 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 |
|---|---|---|---|---|---|---|
| March 25, 2021 | K201878 | ST-Z5 | KCT | Substantially Equivalent | Z-Systems AG | accessdata.fda.gov |
| December 1, 2020 | K201712 | Z5-TL | DZE | Substantially Equivalent | Z-Systems AG | accessdata.fda.gov |
| October 14, 2020 | K200386 | Z5-BL | DZE | Substantially Equivalent | Z-Systems AG | accessdata.fda.gov |
| January 3, 2020 | K190243 | Z5-BL | DZE | Substantially Equivalent | Z-Systems AG | accessdata.fda.gov |
| July 31, 2015 | K150021 | Z5m(t) | DZE | Substantially Equivalent | Z-Systems AG | accessdata.fda.gov |
| July 3, 2014 | K132881 | Z5C | DZE | Substantially Equivalent | Z-Systems AG | accessdata.fda.gov |
| September 5, 2013 | K131701 | Z5MLB, Z5MLC | DZE | Substantially Equivalent | Z-Systems AG | accessdata.fda.gov |
| December 21, 2012 | K120793 | Z-LOOK3 EVO SLM | DZE | Substantially Equivalent | Z-Systems AG | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Updated March 25, 2021. 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.