Manufacturer registered with FDA
Wright Health Group
Dundee, United Kingdom. Lists 6 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 6
- Brands and models
- 10
- 510(k) clearances
- 12013–2013
- Markets registered in
- 57 registrations outside the US
- Establishments
- 1United Kingdom
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Wright Health Group 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 | Wright Health Group | 1 clearances | 2013–2013 | Below |
| Canada | Health Canada | Registration holder | WRIGHT HEALTH GROUP LIMITED | 4 | 2001–2001 | Pure Global AI |
| Australia | TGA | Manufacturer | Wright Health Group Ltd | 1 | 2005–2005 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Wright Health Group Limited | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Wright Health Group 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 Wright Health Group currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | DentavitDentavit Monarch Acrotone Senator DentoriumDentoluuxDentoluux VDentorium | 2011 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Wrights Light Cure Tray Blanks | 2016 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | DentavitDentorium | 2011 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Dentorium Base Plate | 2021 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | Alloy shots and rods Dentoweld | 2015 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2017 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Wright Health Group lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Nats Corp. (1), Cavex Holland BV (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 Sep 2001 | K011820 | DENTORIUM CONVERTIBLE ACRYLIC | Nats Corp. | EBI Rebasing Repairing Relining Denture Resin |
| 16 Jul 2001 | K011419 | CAVEX COLORCHANGE | Cavex Holland BV | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| WRIGHT HEALTH GROUPFDA reg. 3003103749 | Dundee Dundee City, United Kingdom | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10036258). 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.