Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000303432

FEI Number

1000303432

Entity Name

BREDENT GMBH & CO.KG

City/State/Country

SENDEN Bavaria, DE

Establishment Address

WEISSENHORNERSTR. 2, SENDEN Bavaria 89250, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

bredent GmbH & Co. KG (Owner Number: 9027334)

Owner / Operator Contact Address

Weissenhornerstrasse 2, --, Senden, DE-BY 89250, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052779

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2008-09-14
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2010-09-21
EFX	Protector, Silicate	Dental	Class 1	872.6670	2023-09-05
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2006-02-17
KOL	Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer	Dental	Class 1	872.3410	2010-05-26
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2004-06-11
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2016-09-09
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-09-09
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	Class 1	872.3740	2004-06-11
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	1996-08-07
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2006-01-19

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

bredent GmbH & Co. KG

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
K810521	C.Vaupel Dental, Inc.	CO-SPAN 13.5 CASTING ALLOY	1981-03-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

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 1000303432. Last updated year: 2026. Please use registration number 1000303432 when referencing this establishment in official correspondence.