Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023346365

FEI Number

3023346365

Entity Name

EVODEN INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE PRODUTOS ODONTOLOGICOS LTDA.

City/State/Country

Pirassununga Sao Paulo, BR

Establishment Address

R: Genesio de Bem, 1634 Distrito Industrial, Pirassununga Sao Paulo CEP 13633-, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Evoden Industria Comercio Importacao e Exportacao de Produto (Owner Number: 10086171)

Owner / Operator Contact Address

R: Genesio de Bem, 1634 Distrito Industrial, Pirassununga, BR-SP CEP 13633-, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Evoblock Perleon Termoden Evolut HIR Evopack Evoflex Evopour Duolut Ecodent Duodent Evolut Evodent Evotri

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2025-05-09
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2025-05-09
EBE	Coating, Denture Hydrophilic, Resin	Dental	Class 2	872.3300	2025-02-21
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2022-10-19

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

Evoden Industria Comercio Importacao e Exportacao de Produto

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
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
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

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023346365. Last updated year: 2026. Please use registration number 3023346365 when referencing this establishment in official correspondence.