Data / Medical devices / Spain / Union Dental S.A.
Union Dental S.A.: FDA-registered device maker in TIELMES Madrid(Province), Spain, 2 510(k) clearances
Union Dental S.A. is registered with the FDA (registration 3005350578) in TIELMES Madrid(Province), Spain. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 14, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005350578
- Address
- Paseo De La Estacion, 4, TIELMES Madrid(Province), Spain, 28550
- Owner or operator
- UNION DENTAL S.A. (9098488)
- Roles
- Manufacturer
- First device listed
- May 31, 2007
- Registered through
- 2026
- Brand names listed
- 10TEMP, ANAXDENT PMMA BLANK, CORiTEC PMMA DISC Monolayer & Multilayer, ELEDENT, IDODENTINE BLOCK, IDODENTINE DISC, IDOPOL TRAYS, IDOWAX and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 14, 2015 | K150432 | IDODENTINE DISC, IDODENTINE BLOCK | EBG | Substantially Equivalent | Union Dental S.A. | accessdata.fda.gov |
| May 11, 2007 | K070591 | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH | ELM | Substantially Equivalent | Union Dental S.A./Unidesa.Odi | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Prescription
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Denture, Plastic, Teeth
- All makers of Wax, Dental, Intraoral
- All makers of Material, Impression Tray, Resin
Updated August 14, 2015. 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.