Manufacturer registered with FDA
Rhondium, Ltd.
Katikati, New Zealand. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 9
- 510(k) clearances
- 22015–2016
- Markets registered in
- 833 registrations outside the US
- Establishments
- 1New Zealand
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Rhondium, Ltd. 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 | Rhondium, Ltd. | 2 clearances | 2015–2016 | Below |
| European Union | EUDAMED | Manufacturer | Rhondium Limited | 10 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | RHONDIUM LIMITED | 8 | 2017–2018 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Rhondium LtdRHONDIUM LIMITED | 5 | 2024–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Rhondium Limited | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Rhondium Limited | 3 | 2016–2018 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | RHONDIUM LIMITED | 2 | 2024–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Rhondium Ltd | 1 | 2023–2023 | 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 Rhondium, Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Cementing WedgeDME WedgePower RingQuickConnect Anatomy BandQuickConnect CarrierR MatrixSeparator WedgeSure BandSureMatrix | 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 |
|---|---|---|
| RHONDIUM LIMITEDFDA reg. 3011789026 | Katikati Bay of Plenty, New Zealand | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049515). 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.