Data / Medical devices / United Kingdom / Wright Health Group
Wright Health Group: FDA-registered device maker in Dundee Dundee City, United Kingdom, 3 510(k) clearances
Wright Health Group is registered with the FDA (registration 3003103749) in Dundee Dundee City, United Kingdom. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 1, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003103749
- Address
- Dunsinane Avenue Kingsway West, Dundee Dundee City, United Kingdom, DD2 3QD
- Owner or operator
- Wright Health Group (10036258)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 26, 2011
- Registered through
- 2026
- Brand names listed
- Alloy shots and rods Dentoweld, Dentavit, Dentavit Monarch Acrotone Senator Dentorium, Dentoluux, Dentoluux V, Dentorium, Dentorium Base Plate, Wrights Light Cure Tray Blanks
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Other Noble Metal | EJS | 2 | Specification developer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 1, 2013 | K122955 | DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM | ELM | Substantially Equivalent | Wright Health Group , Ltd. | accessdata.fda.gov |
| September 5, 2001 | K011820 | DENTORIUM CONVERTIBLE ACRYLIC | EBI | Substantially Equivalent | Nats Corp. | accessdata.fda.gov |
| July 16, 2001 | K011419 | CAVEX COLORCHANGE | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
Compare with other makers
- All makers of Denture, Plastic, Teeth
- All makers of Alloy, Other Noble Metal
- All makers of Wax, Dental, Intraoral
- All makers of Material, Impression
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Impression Tray, Resin
Updated March 1, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.