Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005350578

FEI Number

3005350578

Entity Name

UNION DENTAL S.A.

City/State/Country

TIELMES Madrid (Province), ES

Establishment Address

PASEO DE LA ESTACION, 4, TIELMES Madrid (Province) 28550, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

UNION DENTAL S.A. (Owner Number: 9098488)

Owner / Operator Contact Address

PASEO DE LA ESTACION, 4, --, TIELMES, MADRID, ES-NOTA 28550, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150432

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2011-12-20
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2007-05-31
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2011-12-20
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2015-09-01
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2015-09-01
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2015-09-01

Official Correspondent

No official correspondent registered.

US Agent Details

Lindsey Fricke Business: FRICKE INTERNATIONAL, INC. Email: lindsey@frickeinternational.comcastbiz.net Phone: (630) 5401900

Related Public Records

Same Entity

UNION DENTAL S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

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3004623350	ASHTEL STUDIOS, INC.	Ontario, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005350578. Last updated year: 2026. Please use registration number 3005350578 when referencing this establishment in official correspondence.