SVENSKA DENTORAMA AB
SE-MF-000040452 · Sweden · Sollentuna / Stockholm
SVENSKA DENTORAMA AB is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 30 |
|---|
Devices declared under this manufacturer
- DENTORAMA WOODEN WEDGES, LARGE
- DENTORAMA WOODEN WEDGES, MIXED
- DENTORAMA WOODEN WEDGES, SMALL
- Dentorama Alu. Instrument Mini Lid
- Dentorama Articulating Paper, curved
- Dentorama Cheek Retractor
- Dentorama Crown Forms
- Dentorama Disposable Plastic Syringes
- Dentorama Hollow Key
- Dentorama Non-Latex Dams
- Dentorama Perf. Alu. Instrument Lid
- Dentorama Rubber Dam Clamps
Showing 12 of 30 declared devices.
Catalogue references include AUX-095, AUX-190-194, DIS-150, DIS-171, EDO-136, EDO-250-276.
European nomenclature codes declared: Q0199, Q019002, Q01010401, Q01020201, Q010199, Q019003.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SVENSKA DENTORAMA AB (SE) · FDA 3003600526 |
| Devices in EUDAMED | 30 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 30 |
|---|---|
| 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: United States only. SVENSKA DENTORAMA AB is registered in the United States but was not found in the Canadian register.