Manufacturer registered with FDA
J.H.Orsing AB
RAA, Sweden. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 16
- 510(k) clearances
- 11994–1994
- Markets registered in
- 714 registrations outside the US
- Establishments
- 1Sweden
510(k) clearances per year, 1990–2026
Registered in 7 markets
Where regulators' registries name J.H.Orsing 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 | J.H.Orsing AB | 1 clearances | 1994–1994 | Below |
| South Korea | MFDS | Manufacturer | J.H.Orsing ABJ.H. ORSING AB | 6 | 2013–2021 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | J H Orsing AB | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | J.H Orsing AB | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | J H Orsing AB | 1 | 2005–2005 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | J.H Orsing AB | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | J.H. ORSING AB | 1 | 2010–2010 | 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 J.H.Orsing 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 | Hygoformic BioHygoformic LHygoformic USoft adapterSoft adapter Bio | 1992 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | CareShieldHygosurgeHygotipHygotip XL BioHygovacHygovac BioHygovac Vent BioScantubeScantube BioScantube Vent Bio 1 moreSpotnix Bio | 2016 |
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 |
|---|---|---|
| J.H.ORSING ABFDA reg. 8030905 | Helsingborg Skane, Sweden | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030905). 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.