{
  "companyId": "71682",
  "slug": "heraeus-kulzer-llc-71682",
  "name": "Heraeus Kulzer, LLC.",
  "clearances": {
    "total": 166,
    "last12Months": 0,
    "first": "1988-10-25",
    "latest": "2013-05-17"
  },
  "medianReviewDays": 76,
  "productCodeCount": 60,
  "recalls": {
    "total": 6,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1651-2014",
        "productCode": "LBH",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2014-04-23",
        "reason": "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\ntime. 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."
      },
      {
        "resNumber": "Z-1133-2014",
        "productCode": "KZP",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2014-02-10",
        "reason": "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"
      },
      {
        "resNumber": "Z-0624-05",
        "productCode": "ELW",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2003-11-01",
        "reason": "Packaging defects could result in improper mixing ratios and unusable impressions."
      },
      {
        "resNumber": "Z-0625-05",
        "productCode": "ELW",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2003-11-01",
        "reason": "Packaging defects could result in improper mixing ratios and unusable impressions."
      },
      {
        "resNumber": "Z-0626-05",
        "productCode": "ELW",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2003-11-01",
        "reason": "Packaging defects could result in improper mixing ratios and unusable impressions."
      }
    ]
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
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    {
      "code": "ELW",
      "deviceName": "Material, Impression",
      "clearances": 21,
      "latest": "2013-05-17",
      "medianReviewDays": 74
    },
    {
      "code": "KLE",
      "deviceName": "Agent, Tooth Bonding, Resin",
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      "latest": "2012-12-07",
      "medianReviewDays": 75
    },
    {
      "code": "EBF",
      "deviceName": "Material, Tooth Shade, Resin",
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      "latest": "2011-12-14",
      "medianReviewDays": 56
    },
    {
      "code": "EBI",
      "deviceName": "Resin, Denture, Relining, Repairing, Rebasing",
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      "latest": "2011-09-29",
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    },
    {
      "code": "CGA",
      "deviceName": "Glucose Oxidase, Glucose",
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      "latest": "1994-05-10",
      "medianReviewDays": 102
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    {
      "code": "CFR",
      "deviceName": "Hexokinase, Glucose",
      "clearances": 6,
      "latest": "1995-06-01",
      "medianReviewDays": 86
    },
    {
      "code": "LCP",
      "deviceName": "Assay, Glycosylated Hemoglobin",
      "clearances": 4,
      "latest": "1995-05-05",
      "medianReviewDays": 139
    },
    {
      "code": "EJT",
      "deviceName": "Alloy, Gold-Based Noble Metal",
      "clearances": 3,
      "latest": "2004-03-03",
      "medianReviewDays": 51
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    {
      "code": "ELM",
      "deviceName": "Denture, Plastic, Teeth",
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      "latest": "2006-05-22",
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    },
    {
      "code": "GKZ",
      "deviceName": "Counter, Differential Cell",
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      "code": "LOD",
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      "code": "CIT",
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    },
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      "code": "CKA",
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      "medianReviewDays": 49
    },
    {
      "code": "EBG",
      "deviceName": "Crown And Bridge, Temporary, Resin",
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      "latest": "1993-12-10",
      "medianReviewDays": 101
    },
    {
      "code": "EBH",
      "deviceName": "Material, Impression Tray, Resin",
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      "latest": "1993-06-18",
      "medianReviewDays": 75
    },
    {
      "code": "EBZ",
      "deviceName": "Activator, Ultraviolet, For Polymerization",
      "clearances": 2,
      "latest": "2004-09-08",
      "medianReviewDays": 26
    },
    {
      "code": "EGD",
      "deviceName": "Wax, Dental, Intraoral",
      "clearances": 2,
      "latest": "1992-11-17",
      "medianReviewDays": 98
    },
    {
      "code": "EIH",
      "deviceName": "Powder, Porcelain",
      "clearances": 2,
      "latest": "2005-10-25",
      "medianReviewDays": 40
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    {
      "code": "JJE",
      "deviceName": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use",
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      "medianReviewDays": 81
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      "code": "JJQ",
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    },
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      "latest": "1994-10-31",
      "medianReviewDays": 48
    },
    {
      "code": "KQO",
      "deviceName": "Automated Urinalysis System",
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      "latest": "1995-02-22",
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    },
    {
      "code": "LBS",
      "deviceName": "Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl",
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      "latest": "1989-12-27",
      "medianReviewDays": 87
    },
    {
      "code": "LMC",
      "deviceName": "Camera, Multi Format, Radiological",
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    },
    {
      "code": "LMD",
      "deviceName": "System, Digital Image Communications, Radiological",
      "clearances": 2,
      "latest": "1994-01-05",
      "medianReviewDays": 114
    }
  ],
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  "productCodesTotal": "60",
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    {
      "kNumber": "K130647",
      "deviceName": "XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML",
      "productCode": "ELW",
      "decisionDate": "2013-05-17",
      "reviewDays": 67
    },
    {
      "kNumber": "K123278",
      "deviceName": "IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF",
      "productCode": "KLE",
      "decisionDate": "2012-12-07",
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    },
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      "deviceName": "FLEXITIME FAST & SCAN LIGHT FLOW",
      "productCode": "ELW",
      "decisionDate": "2012-07-25",
      "reviewDays": 120
    },
    {
      "kNumber": "K113574",
      "deviceName": "FLEXITIME MONOPHASE PRO SCAN",
      "productCode": "ELW",
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    {
      "kNumber": "K112501",
      "deviceName": "VENUS PEARL PLT REFILL A1",
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      "reviewDays": 106
    },
    {
      "kNumber": "K111832",
      "deviceName": "PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID",
      "productCode": "EBI",
      "decisionDate": "2011-09-29",
      "reviewDays": 93
    },
    {
      "kNumber": "K110037",
      "deviceName": "PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID",
      "productCode": "EBI",
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    },
    {
      "kNumber": "K102770",
      "deviceName": "FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW",
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      "decisionDate": "2010-12-21",
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    },
    {
      "kNumber": "K101617",
      "deviceName": "FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL",
      "productCode": "ELW",
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      "reviewDays": 90
    },
    {
      "kNumber": "K093575",
      "deviceName": "GLUMA DESENSITIZER POWER GEL",
      "productCode": "LBH",
      "decisionDate": "2010-03-05",
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  "nameVariants": {
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    "shown": [
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        "name": "Heraeus Kulzer Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Heraeus Kulzer, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Heraeus Kulzer, LLC",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Heraeus Kulzer, LLC.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Heraeus Kulzer, LLC.",
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        "method": "normalised"
      },
      {
        "name": "Heraeus Kulzer,GmbH",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
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    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Heraeus%20Kulzer%2C%20LLC.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Heraeus%20Kulzer%2C%20LLC.%22"
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  "retrievedAt": "2026-08-11T14:48:53.032Z"
}