KULZER GMBH

FDA Device Registration & Listing · HANAU Hesse, DE · Registration 3005665377

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005665377
FEI Number
3005665377
Entity Name
KULZER GMBH
City/State/Country
HANAU Hesse, DE
Establishment Address
Leipziger StraBe 2, HANAU Hesse D-63450, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Kulzer, LLC (Owner Number: 9056636)
Owner / Operator Contact Address
4315 S. Lafayette Blvd., South Bend, IN 46614, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K971155
PMA Number
N/A

All Registered Proprietary Names

Translux Wave Translux 2 Wave TRANSLUX POWER BLUE Flexitime Light Flow Flexitime Medium Flow Artic Digital Artic Flexitime Monophase Flexitime Easy Putty Flexitime Heavy Tray Flexitime Correct Flow Flexitime Unlimited MONDIAL Mondial I iBond Total Etch Gluma Comfort Bond + Desensitizer Paladon 65 Venus Temp 2 Flexitime Bite Dima Print Splint Clear IVORY RUBBER DAM CLAMP Ivory Rubber Dam Complete Kit Ivory Rubber Dam Starter Kit IVORY RUBBER DAM INTRO KIT Starlight Pro dima Print Teeth & Temp Venus Supra Signum Opaque F FLEXITIME XTREME 2 Venus Flow Dispensing Gun 10:1 Dispensing Gun 2 (1:12:1) Dispensing Gun 4:1 Charisma ibond Etch 35 Fluid Delara Palabond Dynamix Speed 2 Cuttersil Light Cuttersil Putty Plus Signum Connector CUTTERSIL MUCOSA Venus Diamond Flow Dima Print Impression Blue Signum composite flow Signum cre-active Signum liquid Signum metal bond Signum universal bond Signum composite Signum matrix IBond Universal and iBond Ceramic Primer Ivory Ivory Rubber Dam Frame dima Print Denture Base 2 iBond Etch 35 Gel Gluma Etch 35 Gel IVORY RUBBER DAM FORCEPS Kulzer PLT Applicator Venus Diamond Venus Diamond ONE Palaseal Protective Sleeves for Syringes (Minitube) Retraxil blue Flexitime Dynamix Heavy Tray Flexitime Dynamix Putty Flexitime Dynamix Monophase Flexitime Magnum 360 dima Denture Base dima Print Try-In Flexitime dynamix mixing tips Mixing Tips: Green Flow Canules IOT White 96 IOT Yellow 96 BITE REG INTRAORAL HIP CD 96 Venus Pearl Venus Pearl ONE Venus Bulk Flow ONE Cuttersil Hardener Memoreg 2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2006-09-21
ELW Material, Impression Dental Class 2 872.3660 2013-04-11
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2006-09-11
ELW Material, Impression Dental Class 2 872.3660 2013-05-28
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2006-09-15
LBH Varnish, Cavity Dental Class 2 872.3260 2013-04-10
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2013-04-10
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2013-06-03
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2025-09-05
ELW Material, Impression Dental Class 2 872.3660 2013-04-11
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2017-05-31
EEF Clamp, Rubber Dam Dental Class 1 872.6300 1996-05-13
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2023-06-16
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
EHJ Disk, Abrasive Dental Class 1 872.6010 2007-01-16
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 2006-09-20
DZN Instruments, Dental Hand Dental Class 1 872.4565 2013-12-12
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2017-03-17
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2013-05-28
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2019-08-16
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2013-04-10
EFD Amalgamator, Dental, Ac-Powered Dental Class 1 872.3100 2021-11-22
ELW Material, Impression Dental Class 2 872.3660 2016-09-07
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-10-23
ELW Material, Impression Dental Class 2 872.3660 2013-04-11
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
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2006-09-20
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 2015-07-08
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2015-07-08
EJE Frame, Rubber Dam Dental Class 1 872.6300 2009-08-31
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2025-08-22
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2014-03-14
EJG Forceps, Rubber Dam Clamp Dental Class 1 872.6300 1996-05-13
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2016-02-05
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-04-10
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2013-07-11
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2023-11-07
MVL Cord, Retraction Unknown Class U N/A 2026-04-17
ELW Material, Impression Dental Class 2 872.3660 2013-04-11
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2018-01-15
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 1996-06-11
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-04-10
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2022-11-16
ELW Material, Impression Dental Class 2 872.3660 2013-08-12
ELW Material, Impression Dental Class 2 872.3660 2014-03-25

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
9610902 KULZER GMBH WEHRHEIM Hesse, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K254063 Kulzer, LLC iCEM Universal Plus 2025-12-19
K243921 Foshan Coxo Medical Instrument Co., Ltd. LED Curing Lights (DB686 HALO) 2025-04-11
K033201 Apoza Enterprise Co., Ltd. LA500 BLUE LIGHT 2003-12-02
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13
K070591 Union Dental S.A./Unidesa.Odi REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH 2007-05-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
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.).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005665377. Last updated year: 2026. Please use registration number 3005665377 when referencing this establishment in official correspondence.
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