Data / Medical devices / Belgium / Elemental NV
Elemental NV: FDA-registered device maker in Ghent Oost-Vlaanderen, Belgium, 1 510(k) clearance
Elemental NV is registered with the FDA (registration 3016505723) in Ghent Oost-Vlaanderen, Belgium. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 3, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016505723
- Address
- Zuiderlaan 1 - 3 #8, Ghent Oost-Vlaanderen, Belgium, 9000
- Owner or operator
- Zinkh NV (10080587)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- August 24, 2022
- Registered through
- 2026
- Brand names listed
- Elemental Granulate, Elemental PerioPlast
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Oral Wound Dressing | OLR | U | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| January 3, 2025 | K241283 | Elemental Granulate | OLR | Substantially Equivalent | Zinkh NV | accessdata.fda.gov |
Compare with other makers
Updated January 3, 2025. 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.