Manufacturer registered with FDA
Tupel Ltd
Oxford, United Kingdom. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 47 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 4 markets
Where regulators' registries name Tupel 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 | Tupel Ltd | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Tupel Ltd. | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Tupel Ltd | 2 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Tupel Ltd. | 2 | — | 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 Tupel 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 |
|---|---|---|---|---|
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Tupel 3D Implant ScannerTupel 3D Scan-Tracks | 2021 |
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 |
|---|---|---|
| TUPEL LTDFDA reg. 3015786035 | Oxford Oxfordshire, United Kingdom | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083253). 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.