Data / Medical devices / Germany / Zfx GmbH
Zfx GmbH: FDA-registered device maker in Dachau Bavaria, Germany, 1 510(k) clearance
Zfx GmbH is registered with the FDA (registration 3008932779) in Dachau Bavaria, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 1, 2024. 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
- 3008932779
- Address
- Kopernikusstr. 15, Dachau Bavaria, Germany, 85221
- Owner or operator
- ZimVie US Corp LLC (1038806)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 26, 2002
- Registered through
- 2026
- Brand names listed
- Dental Accessories for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant SystemsDental Accessories for Spl, GenTek
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, 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 1, 2024 | K231915 | Zfx Abutments | NHA | Substantially Equivalent | Zfx GmbH - A Company of Zimvie | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
Updated March 1, 2024. 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.