Manufacturer registered with FDA
Union Dental S.A.
TIELMES, MADRID, Spain. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 25
- 510(k) clearances
- 12015–2015
- Markets registered in
- 4307 registrations outside the US
- Establishments
- 1Spain
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Union Dental S.A. 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 | Union Dental S.A. | 1 clearances | 2015–2015 | Below |
| European Union | EUDAMED | Registration holder | UNION DENTAL S.A. | 305 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | UNION DENTAL S.A. | 1 | 2010–2010 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | UNION DENTAL, S.A. | 1 | 2010–2010 | 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 Union Dental S.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | ANAXDENT PMMA BLANKCORiTEC PMMA DISC Monolayer & MultilayerIDODENTINE BLOCKIDODENTINE DISCZ-TEMP PMMA DISK10TEMP | 2015 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | IDOPOL TRAYS | 2011 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | ANAXDENT PMMA BLANKCORiTEC PMMA DISC Monolayer & MultilayerIDODENTINE BLOCKIDODENTINE DISCZ-TEMP PMMA DISK10TEMP | 2015 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | IDOWAXODIWAX | 2011 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | ELEDENTNATURE'S BESTODIDENTODILUXODIMAXODIPALODIPAL NEOORTOLUX TOPREPLICAVITACRILIC | 2007 |
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
Union Dental S.A. 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: Union Dental S.A./Unidesa.Odi (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 May 2007 | K070591 | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH | Union Dental S.A./Unidesa.Odi | ELM Teeth Plastic Denture |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| UNION DENTAL S.A.FDA reg. 3005350578 | TIELMES Madrid(Province), Spain | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9098488). 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.