Manufacturer registered with FDA
Xenopus Inc.
Morrisburg, Canada. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 915 registrations outside the US
- Establishments
- 1Canada
Registered in 9 markets
Where regulators' registries name Xenopus Inc. 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 | Xenopus Inc. | 1 device types | — | Below |
| Israel | AMAR | Manufacturer | Xenopus Inc. | 4 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | XENOPUS, INC. | 3 | 2007–2011 | Pure Global AI |
| Australia | TGA | Manufacturer | Xenopus Inc | 2 | 2019–2022 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Xenopus Inc. | 2 | 2013–2014 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | XENOPUS INC. | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Xenopus Inc. | 1 | 2025–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Xenopus Inc. | 1 | 2010–2010 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | XENOPUS INC. | 1 | 2017–2017 | 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 Xenopus Inc. 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 BurEJL · Class 1 | Dental burs & diamonds | Maker | Tri Hawk | 2008 |
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 |
|---|---|---|
| Xenopus Inc.FDA reg. 3002570326 | Morrisburg Ontario, Canada | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027650). 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.