Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610902

FEI Number

3002807166

Entity Name

KULZER GMBH

City/State/Country

WEHRHEIM Hesse, DE

Establishment Address

PHILIPP-REIS-STRASSE 8/13, WEHRHEIM Hesse D-61273, 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

Signum Opaque F FLEXITIME MONOPHASE PRO SCAN Charisma Palaseal Palabond ibond Etch 35 Fluid IBond Universal and iBond Ceramic Primer Venus Diamond Flow iBond Etch 35 Gel Gluma Etch 35 Gel PALA cre-active Pala Digital Denture Tray Refill Pala Digital Impression Tray Universal Silicone Adhesive Pala Digital Denture Starter Kit Venus Diamond Flow Venus Diamond Venus Pearl Venus Bulk Flow One dima Print Teeth & Temp Charisma ABC Venus Pearl Venus Pearl ONE Signum composite flow Signum cre-active Signum liquid Signum metal bond Signum universal bond Signum composite Signum matrix Venus Bulk Flow ONE Signum Connector Venus Flow

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-09-13
ELW	Material, Impression	Dental	Class 2	872.3660	2013-04-11
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-03-17
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2013-07-11
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2013-04-10
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2013-05-28
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2015-07-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2015-07-08
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2013-04-10
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2013-04-10
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2014-03-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-10-23
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2021-01-21
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2026-04-20
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2026-04-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-04-20
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2025-01-23
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2025-01-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-04-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-04-10
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2024-11-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-11-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-11-16
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-10-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2006-09-20

Official Correspondent

No official correspondent registered.

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
3006610834	KULZER GMBH	WASSERBURG Bavaria, 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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

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.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610902. Last updated year: 2026. Please use registration number 9610902 when referencing this establishment in official correspondence.