Manufacturer registered with FDA
Makevale Ltd.
WARE, HERTFORDSHIRE, United Kingdom. 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
- 410 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 4 markets
Where regulators' registries name Makevale 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 | Makevale Ltd. | 1 device types | — | Below |
| Canada | Health Canada | Registration holder | MAKEVALE LTD | 6 | 2013–2013 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Makevale Ltd. | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Makevale Ltd. | 1 | — | 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 Makevale 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 |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Excel Formula Acrylics | 2007 |
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 |
|---|---|---|
| MAKEVALE, LTD.FDA reg. 9680348 | WARE, HERTFORDSHIRE, United Kingdom | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9008390). 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.