Data / Medical devices / Germany / VDW GMBH
VDW GMBH: FDA-registered device maker in MUNICH Bavaria, Germany, 1 510(k) clearance
VDW GMBH is registered with the FDA (registration 9611053) in MUNICH Bavaria, Germany. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 31, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611053
- FEI number
- 3002808442
- Address
- Bayerwaldstrasse 15, MUNICH Bavaria, Germany, 81737
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 15, 1977
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Broach, Endodontic | EKW | 1 | Manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer | accessdata.fda.gov |
| Locator, Root Apex | LQY | U | Specification developer | accessdata.fda.gov |
| Reamer, Pulp Canal, Endodontic | EKP | 1 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| January 31, 2014 | K131907 | RAYPEX 6 | LQY | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Broach, Endodontic
- All makers of File, Pulp Canal, Endodontic
- All makers of Locator, Root Apex
- All makers of Reamer, Pulp Canal, Endodontic
Updated January 31, 2014. 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.