Manufacturer registered with FDA
Asiga
Alexandria, Australia. Lists 6 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 8
- 510(k) clearances
- 22025–2025
- Markets registered in
- 617 registrations outside the US
- Establishments
- 1Australia
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Asiga 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 | Asiga | 2 clearances | 2025–2025 | Below |
| European Union | EUDAMED | Manufacturer | Asiga | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Asiga Pty Ltd | 3 | 2021–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Asiga Pty Ltd | 3 | 2014–2014 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Asiga | 3 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | ASIGA PTY LTD. | 2 | 2025–2025 | 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 Asiga currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | DentaTOOTH | 2025 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | DentaTRAYDentaTRAY Orange | 2023 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | DentaBASE | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DentaGUIDEDentaTRY | 2023 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | DentaTOOTH | 2023 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | DentaIBT | 2023 |
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 |
|---|---|---|
| ASIGAFDA reg. 3024227208 | Alexandria New South Wales, Australia | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10085950). 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.