Data / Medical devices / Australia / Asiga
Asiga: FDA-registered device maker in Alexandria New South Wales, Australia, 2 510(k) clearances
Asiga is registered with the FDA (registration 3024227208) in Alexandria New South Wales, Australia. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 5, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024227208
- Address
- Unit 2 19-21 Bourke Road, Alexandria New South Wales, Australia, 2015
- Owner or operator
- Asiga (10085950)
- Roles
- Manufacturer
- First device listed
- January 17, 2023
- Registered through
- 2026
- Brand names listed
- DentaBASE, DentaGUIDE, DentaIBT, DentaTOOTH, DentaTRAY, DentaTRAY Orange, DentaTRY
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 5, 2025 | K243370 | DentaTOOTH | EBG | Substantially Equivalent | Asiga Pty, Ltd. | accessdata.fda.gov |
| April 11, 2025 | K243356 | Asiga DentaBASE | EBI | Substantially Equivalent | Asiga Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Material, Impression Tray, Resin
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Indirect Bonding Tray
Updated May 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.