Kulzer GmbH
South Bend, IN, US
KULZER GMBH appears in FDA device records in South Bend, IN. FDA records list 205 510(k) clearances between and , no PMA records and 5 registered establishments. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Kulzer GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Heraeus Kulzer, Inc., Dental Products Division510(k), recall
- Heraeus Kulzer,GmbH510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 205FDA records hold 205 510(k) clearances for Kulzer GmbH between 1981 and 2026. The busiest year on record is 1992, with 32. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 3 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 2 |
| 1985 | 1 |
| 1986 | 3 |
| 1988 | 2 |
| 1989 | 20 |
| 1990 | 13 |
| 1991 | 17 |
| 1992 | 32 |
| 1993 | 23 |
| 1994 | 8 |
| 1995 | 6 |
| 1996 | 3 |
| 1997 | 8 |
| 1998 | 2 |
| 1999 | 7 |
| 2000 | 1 |
| 2001 | 6 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 7 |
| 2005 | 7 |
| 2006 | 3 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | EBF | Substantially Equivalent | |
| K254063 | iCEM Universal Plus | EMA | Substantially Equivalent | |
| K243910 | Retraxil | MVL | Substantially Equivalent | |
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active | EBF | Substantially Equivalent | |
| K233868 | dima Print Teeth & Temp | EBG | Substantially Equivalent | |
| K230644 | Signum opaque F | EBF | Substantially Equivalent | |
| K220605 | Venus Bulk Flow ONE | EBF | Substantially Equivalent | |
| K130647 | XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML | ELW | Substantially Equivalent | |
| K123278 | IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF | KLE | Substantially Equivalent | |
| K120914 | FLEXITIME FAST & SCAN LIGHT FLOW | ELW | Substantially Equivalent | |
| K113574 | FLEXITIME MONOPHASE PRO SCAN | ELW | Substantially Equivalent | |
| K112501 | VENUS PEARL PLT REFILL A1 | EBF | Substantially Equivalent | |
| K111832 | PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID | EBI | Substantially Equivalent | |
| K110037 | PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID | EBI | Substantially Equivalent | |
| K102770 | FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW | ELW | Substantially Equivalent | |
| K101617 | FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL | ELW | Substantially Equivalent | |
| K093575 | GLUMA DESENSITIZER POWER GEL | LBH | Substantially Equivalent | |
| K091635 | VENUS DIAMOND FLOW | EBF | Substantially Equivalent | |
| K091494 | FLEXITIME FLOW | ELW | Substantially Equivalent | |
| K083652 | IBOND TOTAL ETCH | KLE | Substantially Equivalent | |
| K082591 | FLEXITIME BITE | ELW | Substantially Equivalent | |
| K080338 | CUTTERSIL ACTIVATOR UNIVERSAL PLUS | ELW | Substantially Equivalent | |
| K073554 | NEUN | EBF | Substantially Equivalent | |
| K063062 | HKBOND 2006 | KLE | Substantially Equivalent | |
| K062515 | RETENTION FLOW OPAQUE | EBF | Substantially Equivalent | |
| K060994 | MONDIAL | ELM | Substantially Equivalent | |
| K052543 | HERACERAM ZIRKONIA | EIH | Substantially Equivalent | |
| K050085 | OSTEOPAL V | LOD | Substantially Equivalent | |
| K050855 | PALAMED G | LOD | Substantially Equivalent | |
| K050854 | PALACOS LV+G | LOD | Substantially Equivalent | |
| K051006 | IBOND NEXT GENERATION | KLE | Substantially Equivalent | |
| K043504 | PALAIMPACT | EBI | Substantially Equivalent | |
| K043295 | VERSYO.DIRECT | EBI | Substantially Equivalent | |
| K042878 | FLEXITIME XTREME | ELW | Substantially Equivalent | |
| K030052 | OSTIM | LYC | Substantially Equivalent | |
| K042199 | TRANSLUX POWER BLUE | EBZ | Substantially Equivalent | |
| K040859 | HERACERAM PRESS | EIH | Substantially Equivalent | |
| K040043 | NDX-40 ALLOY | EJT | Substantially Equivalent | |
| K034049 | HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM | EJT | Substantially Equivalent | |
| K033628 | ARTIC | ELM | Substantially Equivalent | |
| K033665 | VENUS FLOW | EBF | Substantially Equivalent | |
| K033629 | VERSYO.BOND | EBI | Substantially Equivalent | |
| K030318 | P2 POLYETHER | ELW | Substantially Equivalent | |
| K022612 | IBOND GLUMA INSIDE | KLE | Substantially Equivalent | |
| K020131 | VENUS UNIVERSAL LIGHT CURING COMPOSITE | EBF | Substantially Equivalent | |
| K012341 | TRANSLUX ENERGY | EBZ | Substantially Equivalent | |
| K010541 | PREVISION CHEM | EMA | Substantially Equivalent | |
| K011130 | PREMIUM | ELM | Substantially Equivalent | |
| K010800 | VERSYO.COM | EBI | Substantially Equivalent | |
| K011036 | RD-3008 | EJT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005665377 | 3005665377 | KULZER GMBH | Leipziger StraBe 2, HANAU Hesse D-63450 DE | 2026 | and 14 more, listed in full below |
| 3006610834 | 3006610834 | KULZER GMBH | SchlatterstraBe 2, WASSERBURG Bavaria 88142 DE | 2026 | |
| 9610902 | 3002807166 | KULZER GMBH | PHILIPP-REIS-STRASSE 8/13, WEHRHEIM Hesse D-61273 DE | 2026 | and 2 more, listed in full below |
| 1821514 | 1821514 | KULZER, LLC | 4315 S. Lafayette Blvd., SOUTH BEND, IN 46614 US | 2026 | |
| 3011203516 | 3011203516 | Kulzer SRL | Claderia C3, Sacalaz-Judet Timis 307370 RO | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DLIAcetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
- EBZActivator, Ultraviolet, For Polymerization
- CGXAlkaline Picrate, Colorimetry, Creatinine
- EJJAlloy, Amalgam
- EJTAlloy, Gold-Based Noble Metal
- EFDAmalgamator, Dental, Ac-Powered
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)
- CEKBiuret (Colorimetric), Total Protein
- JIOBlood, Occult, Colorimetric, In Urine
- JFJCatalytic Methods, Amylase
- EMACement, Dental
- EEFClamp, Rubber Dam
- EFTCleanser, Denture, Over The Counter
- EBDCoating, Filling Material, Resin
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JGYColorimetric Method, Triglycerides
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- CICCresolphthalein Complexone, Calcium
- EBGCrown And Bridge, Temporary, Resin
- EIEDam, Rubber
- ELMDenture, Plastic, Teeth
- CIGDiazo Colorimetry, Bilirubin
- EHJDisk, Abrasive
- CEMElectrode, Ion Specific, Potassium
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- EJGForceps, Rubber Dam Clamp
- EJEFrame, Rubber Dam
- CGAGlucose Oxidase, Glucose
- EJBHandle, Instrument, Dental
- CFRHexokinase, Glucose
- DZNInstruments, Dental Hand
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- DYTMaintainer, Space Preformed, Orthodontic
- ELWMaterial, Impression
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- JGZO-Phthalaldehyde, Urea Nitrogen
- EFHPaper, Articulation
- JGJPhotometric Method, Magnesium
- EIHPowder, Porcelain
- CECRadioimmunoassay, Free Thyroxine
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- EBIResin, Denture, Relining, Repairing, Rebasing
- EIGRetractor, All Types
- EBCSealant, Pit And Fissure, And Conditioner
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- EIDSyringe, Restorative And Impression Material
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- JAKSystem, X-Ray, Tomography, Computed
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- EHYTray, Impression, Preformed
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- JJWUrinalysis Controls (Assayed And Unassayed)
- EGDWax, Dental, Intraoral
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1651-2014 | Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations. | The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. If extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. This would cause irritation, burning or blistering. | Class II | Terminated | |
| Z-1133-2014 | BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement. | As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C | Class II | Terminated | |
| Z-0036-2008 | 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. | The material may solidify in the bottle, and thus be rendered unusable. | Terminated | ||
| Z-0035-2008 | 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. | The material may solidify in the bottle, and thus be rendered unusable. | Terminated | ||
| Z-0627-05 | Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582. | Packaging defects could result in improper mixing ratios and unusable impressions. | Terminated | ||
| Z-0626-05 | Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584. | Packaging defects could result in improper mixing ratios and unusable impressions. | Terminated | ||
| Z-0625-05 | Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583. | Packaging defects could result in improper mixing ratios and unusable impressions. | Terminated | ||
| Z-0624-05 | Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585. | Packaging defects could result in improper mixing ratios and unusable impressions. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain