Manufacturer registered with FDA
Svenska Dentorama AB
SOLLENTUNA, Sweden. Lists 11 dental device types with FDA across 1 registered establishment.
- Device types listed
- 11
- Brands and models
- 24
- 510(k) clearances
- 0as applicant
- Markets registered in
- 735 registrations outside the US
- Establishments
- 1Sweden
Registered in 7 markets
Where regulators' registries name Svenska Dentorama AB 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 | Svenska Dentorama AB | 11 device types | — | Below |
| European Union | EUDAMED | Manufacturer | SVENSKA DENTORAMA AB | 11 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SVENSKA DENTORAMA AB | 9 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Svenska Dentorama ABSVENSKA DENTORAMA AB | 8 | 2000–2012 | Pure Global AI |
| Australia | TGA | Manufacturer | Svenska Dentorama AB | 3 | 2003–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Svenska Dentorama AB. | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SVENSKA DENTORAMA AB | 2 | 2006–2006 | 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 Svenska Dentorama AB currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | DENTORAMA ASPIRATOR TUBESDENTORAMA SALIVA EJECTORS | 2000 |
| Articulation PaperEFH · Class 1 | — | Maker | Dentorama Articulating Paper, CurvedDentorama Articulating Paper, Horse-shoe | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | DENTORAMA IMPRESSION TRAY | 1996 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | DENTORAMA ANGLE FOR ASPIRATOR TUBESDENTORAMA ASPIRATOR TUBES | 2017 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | DENTORAMA DISP. PLASTIC SYRINGE | 2007 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Dentorama Non-Latex DamDentorama Rubber DamVividDam Rubber Latex Dam | 2024 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | DENTORAMA CHEEK RETRACTORDENTORAMA INTERDENTAL BRUSHESDENTORAMA JUMBO NAPKIN HOLDERDENTORAMA WOODEN WEDGES | 2007 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | DENTORAMA RUBBER DAM FRAME | 2002 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | DENTORAMA CROSS KEYDENTORAMA G-P SCREW POSTSDENTORAMA HOLLOW KEYDENTORAMA TIT. DENTINE PINSDENTORAMA TIT. SCREW POSTS | 2007 |
| Preformed CrownELZ · Class 1 | — | Maker | DENTORAMA CELLULOID CROWN FORMSDENTORAMA POLYCARBONATE CROWNS | 2007 |
| Plaque Disclosing AgentQJC · Class 1 | — | Maker | Dentorama Disclosing Pellets | 2024 |
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 |
|---|---|---|
| SVENSKA DENTORAMA ABFDA reg. 3003600526 | SOLLENTUNA Stockholm, Sweden | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9011193). 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.