Dental Device Guide
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Manufacturer registered with FDA

Kulzer, LLC

South Bend, IN, United States. Lists 28 dental device types with FDA across 5 registered establishments, and holds 37 510(k) clearances as applicant.

FDA owner/operator9056636Contract manufacturerForeign exporterManufacturerRepacker / relabeler6 clearances in five years
Device types listed
28
Brands and models
134
510(k) clearances
371981–2026
Markets registered in
14615 registrations outside the US
Establishments
5Germany, Romania, United States
1981: 31982: 11983: 21984: 21985: 11986: 31988: 11989: 51990: 71991: 62022: 12023: 12024: 22025: 12026: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 14 markets

Where regulators' registries name Kulzer, LLC as the manufacturer or the registration holder of a device.

All markets
United States: 28 device types listedCanada: 221 registrationsSaudi Arabia: 127 registrationsColombia: 70 registrationsSouth Korea: 45 registrationsTaiwan: 38 registrationsUnited Kingdom: 32 registrationsBrazil: 19 registrationsSerbia: 19 registrationsAustralia: 18 registrationsChina: 12 registrationsEuropean Union: 8 registrationsEgypt: 4 registrationsIsrael: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerKulzer, LLC37 clearances1981–2026Below
CanadaHealth CanadaRegistration holderKULZER GMBHKULZER, LLC2211999–2024Pure Global AI
Saudi ArabiaSFDAManufacturerKulzer GmbH127—Pure Global AI
ColombiaINVIMAManufacturerKULZER GMBH70—Pure Global AI
South KoreaMFDSManufacturerKulzer GmbHKulzer SRL · Kulzer SRL.452007–2026Pure Global AI
TaiwanTFDAManufacturerKulzer GmbHKULZER, LLC · Kulzer SRL · +1382006–2026Pure Global AI
United KingdomMHRAManufacturerKulzer GmbH32—Pure Global AI
BrazilANVISAManufacturerKULZER GMBH192000–2026Pure Global AI
SerbiaALIMSManufacturerKulzer GmbH192023–2026Pure Global AI
AustraliaTGAManufacturerKulzer GmbH182003–2025Pure Global AI
ChinaNMPARegistration holder古莎有限公司Kulzer GmbH古莎有限公司 Kulzer GmbH12—Pure Global AI
European UnionEUDAMEDRegistration holderKULZER GmbHKulzer GmbH8—Pure Global AI
EgyptEDAManufacturerKulzer GmbH,42025–2025Pure Global AI
IsraelAMARManufacturerKulzer GmbH2—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Kulzer, LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Impression MaterialELW · Class 2Impression materialsMaker
Cuttersil HardenerCuttersil LightCUTTERSIL MUCOSACuttersil Putty PlusFlexitime BiteFlexitime Correct FlowFlexitime Dynamix Heavy TrayFlexitime Dynamix MonophaseFlexitime Dynamix PuttyFlexitime Easy Putty
11 more
Flexitime Heavy TrayFlexitime Light FlowFlexitime Magnum 360Flexitime Medium FlowFlexitime MonophaseFLEXITIME MONOPHASE PRO SCANFlexitime UnlimitedFLEXITIME XTREME 2Memoreg 2MEMOSILXantasil
2013
Resin Tooth Shade MaterialEBF · Class 2Dental compositesMaker
CharismaCharisma ABCIBond Universal and iBond Ceramic PrimerPALA cre-activeSignum compositeSignum composite flowSignum ConnectorSignum cre-activeSignum liquidSignum matrix
10 more
Signum metal bondSignum Opaque FSignum universal bondVenus Bulk Flow ONEVenus DiamondVenus Diamond FlowVenus Diamond ONEVenus FlowVenus PearlVenus Pearl ONE
2006
Rebasing Repairing Relining Denture ResinEBI · Class 2Denture resins & teethMaker
dima Denture Basedima Print Denture Base 2dima Print Try-InPalabondPaladon 65PalasealPalpress Vario
2013
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsMaker
Gluma Comfort Bond + DesensitizerGluma DesensitizerGluma Etch 35 GeliBond Etch 35 GeliBond Self EtchiBond Total EtchIBond Universal and iBond Ceramic PrimerVenus Temp 2
2013
Teeth Plastic DentureELM · Class 2Denture resins & teethMaker
ArticArtic DigitalDelaraMONDIALMondial I
2006
Cavity VarnishLBH · Class 2Sealants & varnishesMaker
Gluma Comfort Bond + DesensitizeriBond Total EtchVenus Bulk Flow OneVenus DiamondVenus Diamond FlowVenus Pearl
2013
Pit and Fissure Sealant and ConditionerEBC · Class 2Sealants & varnishesMaker
Venus Bulk Flow OneVenus DiamondVenus Diamond FlowVenus Pearl
2013
Ultraviolet Activator for PolymerizationEBZ · Class 2Curing lightsMaker
ibond Etch 35 FluidStarlight ProTranslux 2 WaveTRANSLUX POWER BLUETranslux Wave
2006
Intraoral Dental WaxEGD · Class 1—Maker
Modern Materials Bite BlocksModern Materials Modern Pink No. 3Modern Materials Shur Wax PinkModern Materials Shur Wax X-Hard PinkModern Materials Square RopesModern Materials Thin-Ex Wax PinkModern Materials Utility Wax StripsModern Materials Yellow Check Bite WafersModern Materials Yellow Wax SheetsSurgident COPRWAX
3 more
Surgident Periphery WaxUtility Square RopesUtility Wax Strips
1996
Preformed Impression TrayEHY · Class 1Impression traysMaker
Pala Digital Denture Starter KitPala Digital Denture Tray RefillPala Digital Impression TrayUniversal Silicone Adhesive
2021
Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2Denture resins & teethMaker
dima Print Teethdima Print Teeth & Temp
2018
Resin Filling Material CoatingEBD · Class 2—Maker
Signum compositeSignum composite flowSignum cre-activeSignum liquidSignum matrixSignum metal bondSignum universal bond
2024
Resin Temporary Crown and BridgeEBG · Class 2Temporary crown & bridge materialsMaker
dima Print Teeth & Temp
2025
Resin Impression Tray MaterialEBH · Class 1Impression traysMaker
dima Print Guide & TrayDima Print Impression Blue
2006
Rubber Dam ClampEEF · Class 1Rubber dam systemsMaker
IVORY RUBBER DAM CLAMPIvory Rubber Dam Complete KitIVORY RUBBER DAM INTRO KITIvory Rubber Dam Starter Kit
1996
Rubber Dam FrameEJE · Class 1Rubber dam systemsMaker
IvoryIvory Rubber Dam Frame
2009
Rubber Dam Clamp ForcepsEJG · Class 1Rubber dam systemsMaker
IVORY RUBBER DAM FORCEPS
1996
Orthodontic Space Preformed MaintainerDYT · Class 1Retainers, expanders & headgearLister
Dima Print Splint Clear
2017
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker
Dispensing Gun 10:1Dispensing Gun 2 (1:12:1)Dispensing Gun 4:1
2013
Ac-Powered Dental AmalgamatorEFD · Class 1—Lister
Dynamix Speed 2
2021
Articulation PaperEFH · Class 1—Lister
Surgident Articulating Paper
1996
Over the Counter Denture CleanserEFT · Class 1Denture cleansers & adhesivesMaker
Pala Brillance Denture CleanserVenus Rapid Fresh Cleanser
2019
Abrasive DiskEHJ · Class 1Polishing & prophylaxisLister
Venus Supra
2007
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsMaker
BITE REG INTRAORAL HIP CD 96Flexitime dynamix mixing tipsFlow CanulesIOT White 96IOT Yellow 96Mixing Tips: Green
1996
Rubber DamEIE · Class 1Rubber dam systemsLister
IVORY RUBBER DAMIvory Rubber Dam Complete KitIvory Rubber Dam Starter KitVenus White Max In-office Whitening KitVenus White Max Light Cure Gingival Barrier
1994
All Types RetractorEIG · Class 1Dental hand instrumentsLister—2025
Dental Instrument HandleEJB · Class 1Dental hand instrumentsLister
Kulzer PLT Applicator
2016
Dental CementEMA · Class 2Dental cementsLister
iCEM Universal Plus
2026

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Kulzer, LLC as the applicant.

Decided510(k)DeviceDevice type
11 Mar 2026K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneEBF Resin Tooth Shade Material
19 Dec 2025K254063iCEM Universal PlusEMA Dental Cement
17 Sep 2024K240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-activeEBF Resin Tooth Shade Material
23 May 2024K233868dima Print Teeth & TempEBG Resin Temporary Crown and Bridge
7 Sep 2023K230644Signum opaque FEBF Resin Tooth Shade Material
21 Apr 2022K220605Venus Bulk Flow ONEEBF Resin Tooth Shade Material
6 Jun 1991K905058PALAVIT LEBH Resin Impression Tray Material
6 Jun 1991K904928PALAVIT GLCEGD Intraoral Dental Wax
3 Jun 1991K910263CHARISMAEBF Resin Tooth Shade Material
29 Apr 1991K910719SILICOATER MDEMA Dental Cement
15 Mar 1991K905131DURAFILL COLOR VSEBF Resin Tooth Shade Material
26 Feb 1991K905302DENTHESIVEKLE Resin Tooth Bonding Agent
13 Nov 1990K904555DURAFILL FLOWEBF Resin Tooth Shade Material
13 Aug 1990K903317DENTALON PLUSEBG Resin Temporary Crown and Bridge
27 Jul 1990K902115PALAPRESS(R) VARIO RESINEBI Rebasing Repairing Relining Denture Resin
26 Jul 1990K902350PALATRAY LC RESIN IMPRESSION TRAY MATERIALEBH Resin Impression Tray Material
22 Jun 1990K901789PALADON(R) 65EBI Rebasing Repairing Relining Denture Resin
15 Jun 1990K901697SILISTOR CERAMIC AND RESIN REPAIR SYSTEMEBF Resin Tooth Shade Material
15 Jun 1990K901681FORMASIL(R)A POLYVINYL SILOXANE LINEELW Impression Material
4 Dec 1989K892453KULZER GLAS-IONOMER CEMENTEMA Dental Cement
22 Jun 1989K892455KULZER ADHESIVE CEMENTEBF Resin Tooth Shade Material
16 Jun 1989K892454KULZER INLAY SYSTEMEBF Resin Tooth Shade Material
16 Jun 1989K892452PALASEAL(R)EBI Rebasing Repairing Relining Denture Resin
14 Jun 1989K892456KULZER TRANSLUX ECEBZ Ultraviolet Activator for Polymerization
18 Mar 1988K875344HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOYEJJ Amalgam Alloy
14 Oct 1986K862546MICROFILL PONTICEBF Resin Tooth Shade Material
22 Sep 1986K863315MULTIFIL(R) VSEBF Resin Tooth Shade Material
22 Sep 1986K863314ESTILUX(R) POSTERIOR CEBF Resin Tooth Shade Material
22 Apr 1985K850965KULZER DENTIN ADHESIVEEBF Resin Tooth Shade Material
4 Dec 1984K843823TRANSLUX CLEBZ Ultraviolet Activator for Polymerization
13 Apr 1984K840176ESTIC MICROFILLEBF Resin Tooth Shade Material
12 Sep 1983K831215DENTACOLOR LIGHT CURING CROWN & BRIDGEEBF Resin Tooth Shade Material
12 Sep 1983K831077DENTALONEBG Resin Temporary Crown and Bridge
29 Jan 1982K813568ESTILUX POSTERIOR XREBF Resin Tooth Shade Material
17 Nov 1981K812889ESTILUX POSTERIOREBF Resin Tooth Shade Material
28 Jul 1981K811668KULZER TRANSLUX VISIBLE LIGHT CURINGEBZ Ultraviolet Activator for Polymerization
1 Jul 1981K811669DURAFILL MICROFILL RESTORATIVE MATERIALEBF Resin Tooth Shade Material

Some of these clearances are listed with FDA today by another company: Sun Medical Co., Ltd. (1).

Also lists devices cleared under other names

Kulzer, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Heraeus Kulzer, LLC (25), Dentca, Inc. (2), Heraeus Kulzer, LLC (Mitsui Chemicals Group) (2), S&C Polymer Silicon- Und Composite Spezialitaten GmbH (1), pro3dure medical GmbH (1), Mectron S.P.A. (1), Heraeus Kulzer, Inc., Dental Products Division (1), Modern Materials (1).

Decided510(k)DeviceApplicantDevice type
6 Jul 2022K221033UniPrime A, UniPrime E, UniPrime E/CS&C Polymer Silicon- Und Composite Spezialitaten GmbHKLE Resin Tooth Bonding Agent
5 May 2021K210298GR-14 Resin Systempro3dure medical GmbHEBI Rebasing Repairing Relining Denture Resin
22 Nov 2017K172398DENTCA DENTURE TeethDentca, Inc.PZY Resin Denture Tooth Preformed Additively Manufactured
3 Mar 2017K162044Dentca Denture Base IIDentca, Inc.EBI Rebasing Repairing Relining Denture Resin
15 Nov 2016K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group)EBF Resin Tooth Shade Material
7 Jul 2015K150933iBond Universal & iBond Ceramic PrimerHeraeus Kulzer, LLC (Mitsui Chemicals Group)KLE Resin Tooth Bonding Agent
17 May 2013K130647XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50MLHeraeus Kulzer, LLCELW Impression Material
7 Dec 2012K123278IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELFHeraeus Kulzer, LLCKLE Resin Tooth Bonding Agent
13 Jul 2012K113574FLEXITIME MONOPHASE PRO SCANHeraeus Kulzer, LLCELW Impression Material
14 Dec 2011K112501VENUS PEARL PLT REFILL A1Heraeus Kulzer, LLCEBF Resin Tooth Shade Material
7 Sep 2010K101617FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILLHeraeus Kulzer, LLCELW Impression Material
7 Dec 2009K092951STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTSMectron S.P.A.EBZ Ultraviolet Activator for Polymerization
3 Sep 2009K091635VENUS DIAMOND FLOWHeraeus Kulzer, LLCEBF Resin Tooth Shade Material
31 Jul 2009K091494FLEXITIME FLOWHeraeus Kulzer, LLCELW Impression Material
21 Jan 2009K083652IBOND TOTAL ETCHHeraeus Kulzer, LLCKLE Resin Tooth Bonding Agent
5 Dec 2008K082591FLEXITIME BITEHeraeus Kulzer, Inc., Dental Products DivisionELW Impression Material
21 Apr 2008K080338CUTTERSIL ACTIVATOR UNIVERSAL PLUSHeraeus Kulzer, LLCELW Impression Material
4 Feb 2008K073554NEUNHeraeus Kulzer, LLCEBF Resin Tooth Shade Material
22 May 2006K060994MONDIALHeraeus Kulzer, LLCELM Teeth Plastic Denture
8 Sep 2004K042199TRANSLUX POWER BLUEHeraeus Kulzer, LLCEBZ Ultraviolet Activator for Polymerization
16 Jan 2004K033628ARTICHeraeus Kulzer, LLCELM Teeth Plastic Denture
30 Dec 2003K033665VENUS FLOWHeraeus Kulzer, LLCEBF Resin Tooth Shade Material
28 Feb 2002K020131VENUS UNIVERSAL LIGHT CURING COMPOSITEHeraeus Kulzer, LLCEBF Resin Tooth Shade Material
1 Feb 2001K003930FLEXTIME MAGNUM 360Heraeus Kulzer, LLCELW Impression Material
5 Apr 2000K000629FLEXTIMEHeraeus Kulzer, LLCELW Impression Material
22 May 1997K971155MEMOREGHeraeus Kulzer, LLCELW Impression Material
7 Oct 1996K962812GLUMA DESENSITIZER/GLUMA 3 PRIMERHeraeus Kulzer, LLCKLE Resin Tooth Bonding Agent
27 Sep 1995K954115ARTGLASS & KEVLOCHeraeus Kulzer, LLCEBF Resin Tooth Shade Material
17 Nov 1992K924024ORTHO WAXHeraeus Kulzer, LLCEGD Intraoral Dental Wax
4 Nov 1992K924422PALABONDHeraeus Kulzer, LLCEBI Rebasing Repairing Relining Denture Resin
11 Mar 1992K914456DENTACOLOR(R) CRE-ACTIVEHeraeus Kulzer, LLCEBF Resin Tooth Shade Material
4 Oct 1991K913537MEMOSIL C.D.Heraeus Kulzer, LLCELW Impression Material
6 Jun 1991K910165CUTTERSIL MUCOSAHeraeus Kulzer, LLCELW Impression Material
12 Jan 1982K812805STEELE'S ECON. PINK BASEPL. WAXES, I-IIIModern MaterialsEGD Intraoral Dental Wax
28 Jan 1977K770113ESTILUX UV SYSTEMDegussa Dental, Inc.EBZ Ultraviolet Activator for Polymerization
15 Oct 1976K760755CUTTER SIL-SILICONE IMPRESSION MATCutter Laboratories, Inc.ELW Impression Material

Registered establishments

EstablishmentLocationWhat it does
KULZER GMBHFDA reg. 3005665377HANAU Hesse, GermanyForeign exporter, Manufacturer, Repacker / relabeler, Specification developer
KULZER GMBHFDA reg. 9610902WEHRHEIM Hesse, GermanyContract manufacturer, Manufacturer
KULZER GMBHFDA reg. 3006610834WASSERBURG Bavaria, GermanyContract manufacturer
Kulzer SRLFDA reg. 3011203516Sacalaz-Judet Timis, RomaniaContract manufacturer
KULZER, LLCFDA reg. 1821514SOUTH BEND, IN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9056636). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.