Polident d.o.o. Industrija dentalnih proizvodov
SI-MF-000000740 · Slovenia · Volcja Draga
Polident d.o.o. Industrija dentalnih proizvodov is registered in the European database on medical devices as a manufacturer, with 4 376 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 4 376 |
|---|
Most frequent device types declared: Type 1/Type 2.
Devices declared under this manufacturer
- Cross linked 2
- DEGOS L-TEMP MultiColor
- K-30 S
- Organic PMMA FD
- Organic PMMA eco
- Ortopoli
- PMMA CAD/CAM disc
- Pink CAD/CAM disc
- Polirepar S
- Politemp
- Primodent
- Ref-Line
Showing 12 of 4 376 declared devices.
Catalogue references include 67-3828, CL.37C2, PMC 9516B1, PMMA.741, PMMAML.574, PRI.32Y4.
European nomenclature codes declared: Q010699, Q0199, Q010503.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 4 376 |
| Country of registration | Slovenia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
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. Polident d.o.o. Industrija dentalnih proizvodov was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR-0014 | restricted | 2029-07-29 |