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Not currently registered with FDA under this name

Heraeus Kulzer, LLC

South Bend, IN, United States. Named as applicant on 91 dental 510(k) clearances between 1990 and 2013. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
911990–2013
Markets registered in
6201 registrations outside the US
Establishments
0—
1990: 11991: 81992: 111993: 51994: 31995: 31996: 31997: 81998: 11999: 72000: 12001: 62002: 22003: 32004: 72005: 42006: 32008: 22009: 32010: 32011: 32012: 32013: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 6 markets

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

All markets
United States: 91 clearancesSouth Korea: 113 registrationsCanada: 49 registrationsSaudi Arabia: 23 registrationsTaiwan: 11 registrationsCosta Rica: 5 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantHeraeus Kulzer, LLC91 clearances1990–2013Below
South KoreaMFDSManufacturerHeraeus Kulzer GmbHHERAEUS-KULZER GMBH · Heraeus-Kulzer,GmbH · +21131998–2017Pure Global AI
CanadaHealth CanadaRegistration holderHERAEUS KULZER GMBH491999–2008Pure Global AI
Saudi ArabiaSFDAManufacturerHeraeus Kulzer GmbH23—Pure Global AI
TaiwanTFDAManufacturerHERAEUS KULZER, LLCHERAEUS KULZER, INC.112006–2021Pure Global AI
Costa RicaMinisterio de SaludManufacturerHeraeus Kulzer GmbH5—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

510(k) clearances

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

Decided510(k)DeviceDevice type
17 May 2013K130647XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50MLELW Impression Material
7 Dec 2012K123278IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELFKLE Resin Tooth Bonding Agent
25 Jul 2012K120914FLEXITIME FAST & SCAN LIGHT FLOWELW Impression Material
13 Jul 2012K113574FLEXITIME MONOPHASE PRO SCANELW Impression Material
14 Dec 2011K112501VENUS PEARL PLT REFILL A1EBF Resin Tooth Shade Material
29 Sep 2011K111832PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUIDEBI Rebasing Repairing Relining Denture Resin
29 Apr 2011K110037PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUIDEBI Rebasing Repairing Relining Denture Resin
21 Dec 2010K102770FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOWELW Impression Material
7 Sep 2010K101617FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILLELW Impression Material
5 Mar 2010K093575GLUMA DESENSITIZER POWER GELLBH Cavity Varnish
3 Sep 2009K091635VENUS DIAMOND FLOWEBF Resin Tooth Shade Material
31 Jul 2009K091494FLEXITIME FLOWELW Impression Material
21 Jan 2009K083652IBOND TOTAL ETCHKLE Resin Tooth Bonding Agent
21 Apr 2008K080338CUTTERSIL ACTIVATOR UNIVERSAL PLUSELW Impression Material
4 Feb 2008K073554NEUNEBF Resin Tooth Shade Material
1 Dec 2006K063062HKBOND 2006KLE Resin Tooth Bonding Agent
22 Nov 2006K062515RETENTION FLOW OPAQUEEBF Resin Tooth Shade Material
22 May 2006K060994MONDIALELM Teeth Plastic Denture
25 Oct 2005K052543HERACERAM ZIRKONIAEIH Porcelain Powder
7 Jun 2005K051006IBOND NEXT GENERATIONKLE Resin Tooth Bonding Agent
28 Jan 2005K043504PALAIMPACTEBI Rebasing Repairing Relining Denture Resin
5 Jan 2005K043295VERSYO.DIRECTEBI Rebasing Repairing Relining Denture Resin
17 Dec 2004K042878FLEXITIME XTREMEELW Impression Material
6 Dec 2004K030052OSTIMLYC Synthetic Bone Grafting Material
8 Sep 2004K042199TRANSLUX POWER BLUEEBZ Ultraviolet Activator for Polymerization
20 May 2004K040859HERACERAM PRESSEIH Porcelain Powder
3 Mar 2004K040043NDX-40 ALLOYEJT Gold-Based Noble Metal Alloy
1 Mar 2004K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMEJT Gold-Based Noble Metal Alloy
16 Jan 2004K033628ARTICELM Teeth Plastic Denture
30 Dec 2003K033665VENUS FLOWEBF Resin Tooth Shade Material
22 Dec 2003K033629VERSYO.BONDEBI Rebasing Repairing Relining Denture Resin
3 Apr 2003K030318P2 POLYETHERELW Impression Material
28 Oct 2002K022612IBOND GLUMA INSIDEKLE Resin Tooth Bonding Agent
28 Feb 2002K020131VENUS UNIVERSAL LIGHT CURING COMPOSITEEBF Resin Tooth Shade Material
30 Aug 2001K012341TRANSLUX ENERGYEBZ Ultraviolet Activator for Polymerization
31 Jul 2001K010541PREVISION CHEMEMA Dental Cement
5 Jul 2001K011130PREMIUMELM Teeth Plastic Denture
31 May 2001K010800VERSYO.COMEBI Rebasing Repairing Relining Denture Resin
10 May 2001K011036RD-3008EJT Gold-Based Noble Metal Alloy
1 Feb 2001K003930FLEXTIME MAGNUM 360ELW Impression Material
5 Apr 2000K000629FLEXTIMEELW Impression Material
22 Dec 1999K993932SOLITAIRE 2EBF Resin Tooth Shade Material
15 Dec 1999K993602PRE-VISION FILLEBF Resin Tooth Shade Material
14 Oct 1999K992985GLUMA COMFORT BONDKLE Resin Tooth Bonding Agent
1 Oct 1999K992292GLUMA COMFORT BOND + DESENSITIZERKLE Resin Tooth Bonding Agent
15 Jun 1999K991425XANTOPREN COMFORTELW Impression Material
7 May 1999K990756FLOW LINEEBF Resin Tooth Shade Material
25 Feb 1999K990143GLUMA ONE BONDKLE Resin Tooth Bonding Agent
4 Feb 1998K974390GLUMA ONE BONDKLE Resin Tooth Bonding Agent
24 Nov 1997K973694PROVIL NOVOELW Impression Material
2 Oct 1997K9717332 BOND 2KLE Resin Tooth Bonding Agent
29 Sep 1997K972101SOLITAIREKLE Resin Tooth Bonding Agent
22 May 1997K971155MEMOREGELW Impression Material
6 May 1997K970848SILOC SYSTEMKLE Resin Tooth Bonding Agent
2 Apr 1997K964038CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FGKLE Resin Tooth Bonding Agent
19 Mar 1997K965165CUTTERSIL COMFORT HARDENERELW Impression Material
19 Mar 1997K965163CUTTERSIL COMFORTELW Impression Material
5 Nov 1996K964140GLUMA CONDITIONERKLE Resin Tooth Bonding Agent
7 Oct 1996K962812GLUMA DESENSITIZER/GLUMA 3 PRIMERKLE Resin Tooth Bonding Agent
26 Jun 1996K961995QUICKSPLINTEBI Rebasing Repairing Relining Denture Resin
27 Nov 1995K954929CHARISMA SINGLE DOSEEBF Resin Tooth Shade Material
2 Oct 1995K953743PALASPLINTEBI Rebasing Repairing Relining Denture Resin
27 Sep 1995K954115ARTGLASS & KEVLOCEBF Resin Tooth Shade Material
7 Apr 1994K940800DENTACOLOR VITA (VS) SHADE SYSTEMEBF Resin Tooth Shade Material
7 Mar 1994K935735ATTACHMENT BONDKLE Resin Tooth Bonding Agent
26 Jan 1994K935736CHARISMA SUPERLIGHTEBF Resin Tooth Shade Material
10 Dec 1993K934283DENTALON PLUS MODIFICATIONEBG Resin Temporary Crown and Bridge
6 Aug 1993K932034PALAVIT 55 AND DENTACOLOR CONNECTOREBG Resin Temporary Crown and Bridge
8 Jul 1993K932013CHARISMA -- MODIFIEDEBF Resin Tooth Shade Material
8 Jul 1993K931838DENTHESIVE IIKLE Resin Tooth Bonding Agent
18 Jun 1993K930487PALATRAY LC MINTEBH Resin Impression Tray Material
17 Nov 1992K924024ORTHO WAXEGD Intraoral Dental Wax
4 Nov 1992K924422PALABONDEBI Rebasing Repairing Relining Denture Resin
29 Sep 1992K923549PALADISC LCEBH Resin Impression Tray Material
16 Sep 1992K915898PALADUREBI Rebasing Repairing Relining Denture Resin
9 Jun 1992K921701DURAFILL BONDKLE Resin Tooth Bonding Agent
19 Mar 1992K914513PALAVIT GEGD Intraoral Dental Wax
11 Mar 1992K914456DENTACOLOR(R) CRE-ACTIVEEBF Resin Tooth Shade Material
3 Feb 1992K915336TWINLOOKEBF Resin Tooth Shade Material
31 Jan 1992K915355ADS-GEL AND INSULATING-GELEBF Resin Tooth Shade Material
21 Jan 1992K915335SILICOATER SYSTEMEBF Resin Tooth Shade Material
17 Jan 1992K915095ESTISEAL LCEBC Pit and Fissure Sealant and Conditioner
9 Oct 1991K913699MODERN MATERIALS ORTHODONTIC RESINEBI Rebasing Repairing Relining Denture Resin
9 Oct 1991K913698ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIALEBI Rebasing Repairing Relining Denture Resin
4 Oct 1991K913537MEMOSIL C.D.ELW Impression Material
6 Jun 1991K910465MELIODENT, DENTURE RESINEBI Rebasing Repairing Relining Denture Resin
6 Jun 1991K910360CUTTERSIL FUNCTION ACTIVATORELW Impression Material
6 Jun 1991K910189PERFOURM PUTTY SOFTELW Impression Material
6 Jun 1991K910166CUTTERSIL XLELW Impression Material
6 Jun 1991K910165CUTTERSIL MUCOSAELW Impression Material
1 Feb 1990K896382MODIFIED GLUMA BONDING SYSTEMKLE Resin Tooth Bonding Agent

Some of these clearances are listed with FDA today by another company: Kulzer, LLC (25), Sunrise Dental Laboratory, Ltd. (1), Ortho Dental Lab, LLC (1), Ultradent Products, Inc. (1).

Sources

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 of the most recent filing, which can be a US agent.