Manufacturer registered with FDA
Zinkh NV
Ghent, Belgium. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Belgium
Registered in 2 markets
Where regulators' registries name Zinkh NV as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Zinkh NV | 2 device types | — | Below |
| Israel | AMAR | Manufacturer | Zinkh NV | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Zinkh NV currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Elemental Granulate | 2022 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Elemental GranulateElemental PerioPlast | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Elemental NVFDA reg. 3016505723 | Ghent Oost-Vlaanderen, Belgium | Foreign exporter, Manufacturer, Specification developer |
Other names on FDA records
Elemental NV
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10080587). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.