FDA Registration
Active
🇪🇸 Spain
UNION DENTAL S.A.
Reg #: 3005350578
·
FEI: 3005350578
·
Expires 2026
Products
6
Proprietary Names
19
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- UNION DENTAL S.A.
- Registration Number
- 3005350578
- FEI Number
- 3005350578
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PASEO DE LA ESTACION, 4
- City
- TIELMES Madrid (Province)
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K070591
Owner / Operator
- Firm Name
- UNION DENTAL S.A.
- Operator Number
- 9098488
- Address
- PASEO DE LA ESTACION, 4, --
- City
- TIELMES, MADRID
- State
- ES-NOTA
- Postal Code
- 28550
- Country
- ES
US Agent
- Business Name
- FRICKE INTERNATIONAL, INC.
- Contact Name
- Lindsey Fricke
- Address
- 165 Roma Jean Pkwy
- City
- Streamwood
- State
- IL
- ZIP
- 60107
- Country
- US
- [email protected]
- Phone
- 630 5401900
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2011-12-20 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2007-05-31 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2011-12-20 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2015-09-01 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2015-09-01 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2015-09-01 |
Proprietary Names
IDOWAX
ODIWAX
NATURE'S BEST
ODILUX
VITACRILIC
ODIPAL NEO
ORTOLUX TOP
ODIPAL
REPLICA
ODIDENT
ODIMAX
ELEDENT
IDOPOL TRAYS
IDODENTINE BLOCK
IDODENTINE DISC
ANAXDENT PMMA BLANK
10TEMP
Z-TEMP PMMA DISK
CORiTEC PMMA DISC Monolayer & Multilayer
Establishment Types
Manufacture Medical Device