Manufacturer registered with FDA
INKA Surgical Instruments
Jandakot, Australia. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 3146 registrations outside the US
- Establishments
- 1Australia
Registered in 3 markets
Where regulators' registries name INKA Surgical Instruments 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 | INKA Surgical Instruments | 9 device types | — | Below |
| Australia | TGA | Registration holder | INKA Surgical Instruments | 140 | 2004–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | INKA Surgical InstrumentsINKA SURGICAL INSTRUMENTS | 6 | 2017–2026 | 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 INKA Surgical Instruments currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | N/A | 2022 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | N/A | 2025 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | N/A | 2022 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | N/A | 2025 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | N/A | 2022 |
| Endodontic Stabilizing SplintELS · Class 2 | — | Maker | N/A | 2025 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | N/A | 2022 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | N/A | 2025 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | N/A | 2022 |
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 |
|---|---|---|
| INKA SURGICAL INSTRUMENTSFDA reg. 3023657851 | Jandakot Western Australia, Australia | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086662). 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.