Alphadent NV
BE-MF-000000923 · Belgium · Waregem
Alphadent NV is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 12 |
|---|
Most frequent device types declared: 2001, 2002B, 2002G, 2004B, 2004G.
Among these devices, 4 are declared reusable.
Devices declared under this manufacturer
- Activating tool
- CEKA M3 SPACE MAINT. 0.3MM 10 PCS
- IMPRESSION TOOLS/ANALOGUES + SPACE MAINTAINERS FOR M3 SIZE - 2+2 PCS.
- M3 IMPRESSION TOOL BASE RING 2 PCS
- PRECI-POST CC reamer A 1 P.
- PRECI-POST DENTIST 50 BL/50 YE
- PRECI-POST DENTIST BLUE 50 PCS
- PRECI-POST DENTIST YELLOW 50 PCS
- PRECI-POST REAMER BLUE 1 P.
- PRECI-POST REAMER YELLOW 1 P.
- PRECI-POST SET
- REVAX M2 SPACE MAINTAINER 10 PCS
Catalogue references include 2001, 2002G, 2002b, 2004G, 694 B, A 1.
European nomenclature codes declared: Q010207, Q010507, Q010699, Q010599, Q010280, Q010299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 12 |
| Share | 100.0 % |
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Alphadent NV was not found in either the U.S. or the Canadian register.