IsoDent Oy
FI-MF-000023346 · Finland · Rovaniemi
IsoDent Oy is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 24 |
|---|
Most frequent device types declared: IsoDent Super Junior mouthwash 100 ml.
Devices declared under this manufacturer
- IsoDent Fluor+ hoitava suuvesi 250ml
- IsoDent Niitty kosteuttava suuvesi 100ml
- IsoDent Ortho puhdistusaine 250ml
- IsoDent Super Junior mouthwash 100 ml
- IsoDent Super Junior mouthwash 250ml
- IsoDent hammasproteesien kiinnitysjauhe
- IsoDent hammasproteesien kiinnitysvoide
- IsoDent hammasproteesien puhdistusaine 250ml
- IsoDent puhdistusharja hammasproteeseille
- IsoDent puhdistusharja purentakiskoille ja muille irrotettaville suuko
- IsoDent suukojeiden ja hammasproteesien puhdistus- ja säilytysrasia
- IsoDent vastaanoton suuvesi 250ml
Showing 12 of 24 declared devices.
Catalogue references include 6430043960049, 6430043960056, 6430043960063, 6430043960094, 6430043960100, 6430043960193.
European nomenclature codes declared: Q01010403, P0399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 24 |
| Country of registration | Finland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 24 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. IsoDent Oy was not found in either the U.S. or the Canadian register.