Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006610834

FEI Number

3006610834

Entity Name

KULZER GMBH

City/State/Country

WASSERBURG Bavaria, DE

Establishment Address

SchlatterstraBe 2, WASSERBURG Bavaria 88142, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Kulzer, LLC (Owner Number: 9056636)

Owner / Operator Contact Address

4315 S. Lafayette Blvd., South Bend, IN 46614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MONDIAL Mondial I Delara Artic Digital Artic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2006-09-15
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2019-08-16
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2006-09-11

Official Correspondent

David Vincent

US Agent Details

David Vincent Business: Kulzer, LLC Email: david.vincent@Kulzer-dental.com Phone: (574) 2995421

Related Public Records

Same Entity

Kulzer, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1821514	KULZER, LLC	SOUTH BEND, IN, US
3011203516	Kulzer SRL	Sacalaz-Judet Timis, RO
9610902	KULZER GMBH	WEHRHEIM Hesse, DE
3005665377	KULZER GMBH	HANAU Hesse, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K254063	Kulzer, LLC	iCEM Universal Plus	2025-12-19
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
3016564992	DENTAC LLC	North Miami, FL, US
3042623520	ZINGO DIGITAL DENTAL LAB LLC	Mount Prospect, IL, US
3010253209	ENTA B.V.	Bergen op Zoom Noord-Brabant, NL
3007740664	Shenzhen Jiahong Dental Technology Co., Ltd	Shenzhen Guangdong, CN
3002727993	GEBDI DENTAL PRODUCTS GMBH	Engen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006610834. Last updated year: 2026. Please use registration number 3006610834 when referencing this establishment in official correspondence.