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Data / Medical devices / Germany / Kulzer GMBH

Kulzer GMBH: FDA-registered device maker in HANAU Hesse, Germany, 45 510(k) clearances

Kulzer GMBH is registered with the FDA (registration 3005665377) in HANAU Hesse, Germany. It lists 24 device types. The FDA files 45 510(k) clearances under its listings, the newest dated March 11, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Kulzer GMBH
FDA registration number
3005665377
Address
Leipziger StraBe 2, HANAU Hesse, Germany, D-63450
Owner or operator
Kulzer, LLC (9056636)
Roles
Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
May 13, 1996
Registered through
2026
Brand names listed
Artic, Artic Digital, BITE REG INTRAORAL HIP CD 96, CUTTERSIL MUCOSA, Charisma, Charisma ABC, Cuttersil Hardener, Cuttersil Light and more

Devices it lists

DeviceProduct codeClassRoleSource
Activator, Ultraviolet, For PolymerizationEBZ2Exporter to the US, Specification developeraccessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture ToothPZY2Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Exporter to the US, Specification developeraccessdata.fda.gov
Amalgamator, Dental, Ac-PoweredEFD1Exporter to the USaccessdata.fda.gov
Clamp, Rubber DamEEF1Specification developeraccessdata.fda.gov
Coating, Filling Material, ResinEBD2Exporter to the US, Specification developeraccessdata.fda.gov
Cord, RetractionMVLUExporter to the US, Specification developeraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Exporter to the US, Manufactureraccessdata.fda.gov
Dental Barriers And SleevesPEM2Exporter to the USaccessdata.fda.gov
Denture, Plastic, TeethELM2Exporter to the US, Specification developeraccessdata.fda.gov
Disk, AbrasiveEHJ1Exporter to the USaccessdata.fda.gov
Forceps, Rubber Dam ClampEJG1Specification developeraccessdata.fda.gov
Frame, Rubber DamEJE1Specification developeraccessdata.fda.gov
Handle, Instrument, DentalEJB1Exporter to the USaccessdata.fda.gov
Instruments, Dental HandDZN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Exporter to the USaccessdata.fda.gov
Material, ImpressionELW2Exporter to the US, Specification developeraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Exporter to the US, Manufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Exporter to the US, Specification developeraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Exporter to the US, Repackager or relabeler, Specification developeraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Specification developeraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Exporter to the USaccessdata.fda.gov
Varnish, CavityLBH2Exporter to the US, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 11, 2026K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneEBFSubstantially EquivalentKulzer, LLCaccessdata.fda.gov
September 24, 2025K243910RetraxilMVLSubstantially EquivalentKulzer, LLCaccessdata.fda.gov
September 17, 2024K240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-activeEBFSubstantially EquivalentKulzer, LLCaccessdata.fda.gov
May 23, 2024K233868dima Print Teeth & TempEBGSubstantially EquivalentKulzer, LLCaccessdata.fda.gov
September 7, 2023K230644Signum opaque FEBFSubstantially EquivalentKulzer, LLCaccessdata.fda.gov
July 6, 2022K221033UniPrime A, UniPrime E, UniPrime E/CKLESubstantially EquivalentS&C Polymer Silicon- Und Composite Spezialitäten GmbHaccessdata.fda.gov
April 21, 2022K220605Venus Bulk Flow ONEEBFSubstantially EquivalentKulzer, LLCaccessdata.fda.gov
August 3, 2021K211026Minitube Dentasleeve Protective Barrier SleevesPEMSubstantially EquivalentMinitube ABaccessdata.fda.gov
May 5, 2021K210298GR-14 Resin SystemEBISubstantially EquivalentPro3Dure Medical GmbHaccessdata.fda.gov
November 22, 2017K172398DENTCA DENTURE TeethPZYSubstantially EquivalentDentca, Inc.accessdata.fda.gov
March 3, 2017K162044Dentca Denture Base IIEBISubstantially EquivalentDentca, Inc.accessdata.fda.gov
November 15, 2016K160049CharismaEBFSubstantially EquivalentHeraeus Kulzer, LLC (Mitsui Chemicals Group)accessdata.fda.gov
July 7, 2015K150933iBond Universal & iBond Ceramic PrimerKLESubstantially EquivalentHeraeus Kulzer, LLC, Mitsui Chemicals Groupaccessdata.fda.gov
May 17, 2013K130647XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50MLELWSubstantially EquivalentHeraeus Kulzer, LLCaccessdata.fda.gov
July 13, 2012K113574FLEXITIME MONOPHASE PRO SCANELWSubstantially EquivalentHeraeus Kulzer, LLCaccessdata.fda.gov
December 14, 2011K112501VENUS PEARL PLT REFILL A1EBFSubstantially EquivalentHeraeus Kulzer, LLCaccessdata.fda.gov
September 7, 2010K101617FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILLELWSubstantially EquivalentHeraeus Kulzer, LLCaccessdata.fda.gov
December 7, 2009K092951STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTSEBZSubstantially EquivalentMectron S.P.A.accessdata.fda.gov
September 3, 2009K091635VENUS DIAMOND FLOWEBFSubstantially EquivalentHeraeus Kulzer, LLCaccessdata.fda.gov
July 31, 2009K091494FLEXITIME FLOWELWSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
January 21, 2009K083652IBOND TOTAL ETCHKLESubstantially EquivalentHeraeus Kulzer,GmbHaccessdata.fda.gov
December 5, 2008K082591FLEXITIME BITEELWSubstantially EquivalentHeraeus Kulzer, Inc., Dental Products Divisionaccessdata.fda.gov
April 21, 2008K080338CUTTERSIL ACTIVATOR UNIVERSAL PLUSELWSubstantially EquivalentHeraeus Kulzer,GmbHaccessdata.fda.gov
February 4, 2008K073554NEUNEBFSubstantially EquivalentHeraeus Kulzer,GmbHaccessdata.fda.gov
May 22, 2006K060994MONDIALELMSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
September 8, 2004K042199TRANSLUX POWER BLUEEBZSubstantially EquivalentHeraeus Kulzer,GmbHaccessdata.fda.gov
January 16, 2004K033628ARTICELMSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
December 30, 2003K033665VENUS FLOWEBFSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
February 28, 2002K020131VENUS UNIVERSAL LIGHT CURING COMPOSITEEBFSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
February 1, 2001K003930FLEXTIME MAGNUM 360ELWSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
April 5, 2000K000629FLEXTIMEELWSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
May 22, 1997K971155MEMOREGELWSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
October 7, 1996K962812GLUMA DESENSITIZER/GLUMA 3 PRIMERKLESubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
September 27, 1995K954115ARTGLASS & KEVLOCEBFSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
November 4, 1992K924422PALABONDEBISubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
March 11, 1992K914456DENTACOLOR(R) CRE-ACTIVEEBFSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
October 4, 1991K913537MEMOSIL C.D.ELWSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
June 6, 1991K910165CUTTERSIL MUCOSAELWSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
June 6, 1991K905058PALAVIT LEBHSubstantially EquivalentKulzer, Inc.accessdata.fda.gov
February 26, 1991K905302DENTHESIVEKLESubstantially EquivalentKulzer, Inc.accessdata.fda.gov
July 27, 1990K902115PALAPRESS(R) VARIO RESINEBISubstantially EquivalentKulzer, Inc.accessdata.fda.gov
June 22, 1990K901789PALADON(R) 65EBISubstantially EquivalentKulzer, Inc.accessdata.fda.gov
June 16, 1989K892452PALASEAL(R)EBISubstantially EquivalentKulzer, Inc.accessdata.fda.gov
January 28, 1977K770113ESTILUX UV SYSTEMEBZSubstantially EquivalentDegussa Dental, Inc.accessdata.fda.gov
October 15, 1976K760755CUTTER SIL-SILICONE IMPRESSION MATELWSubstantially EquivalentCutter Laboratories, Inc.accessdata.fda.gov

Compare with other makers

Updated March 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.