{
  "companyId": "52045",
  "slug": "ultradent-products-inc-52045",
  "name": "Ultradent Products, Inc.",
  "clearances": {
    "total": 104,
    "last12Months": 2,
    "first": "1992-06-16",
    "latest": "2026-07-01"
  },
  "medianReviewDays": 73,
  "productCodeCount": 22,
  "recalls": {
    "total": 20,
    "openLast12Months": 1,
    "recent": [
      {
        "resNumber": "Z-1689-2026",
        "productCode": "EHJ",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-01-28",
        "reason": "Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment."
      },
      {
        "resNumber": "Z-3066-2024",
        "productCode": "EBF",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-08-02",
        "reason": "Due to a manufacturing issue, red particulates present in the expressed composite."
      },
      {
        "resNumber": "Z-3067-2024",
        "productCode": "EBF",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-08-02",
        "reason": "Due to a manufacturing issue, red particulates present in the expressed composite."
      },
      {
        "resNumber": "Z-3068-2024",
        "productCode": "EBF",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-08-02",
        "reason": "Due to a manufacturing issue, red particulates present in the expressed composite."
      },
      {
        "resNumber": "Z-1368-2022",
        "productCode": "KLE",
        "status": "Completed",
        "recallClass": "Class II",
        "initiated": "2022-06-01",
        "reason": "SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer."
      }
    ]
  },
  "registration": {
    "sites": 1,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "KLE",
      "deviceName": "Agent, Tooth Bonding, Resin",
      "clearances": 19,
      "latest": "2024-03-20",
      "medianReviewDays": 46
    },
    {
      "code": "EBF",
      "deviceName": "Material, Tooth Shade, Resin",
      "clearances": 17,
      "latest": "2026-07-01",
      "medianReviewDays": 70
    },
    {
      "code": "EMA",
      "deviceName": "Cement, Dental",
      "clearances": 9,
      "latest": "2021-07-13",
      "medianReviewDays": 55
    },
    {
      "code": "LBH",
      "deviceName": "Varnish, Cavity",
      "clearances": 9,
      "latest": "2026-04-30",
      "medianReviewDays": 70
    },
    {
      "code": "EBC",
      "deviceName": "Sealant, Pit And Fissure, And Conditioner",
      "clearances": 7,
      "latest": "2011-09-23",
      "medianReviewDays": 99
    },
    {
      "code": "EBZ",
      "deviceName": "Activator, Ultraviolet, For Polymerization",
      "clearances": 7,
      "latest": "2022-02-22",
      "medianReviewDays": 48
    },
    {
      "code": "EJK",
      "deviceName": "Liner, Cavity, Calcium Hydroxide",
      "clearances": 5,
      "latest": "1997-04-02",
      "medianReviewDays": 68
    },
    {
      "code": "KIF",
      "deviceName": "Resin, Root Canal Filling",
      "clearances": 5,
      "latest": "2021-10-13",
      "medianReviewDays": 35
    },
    {
      "code": "KJJ",
      "deviceName": "Cleanser, Root Canal",
      "clearances": 5,
      "latest": "2018-02-09",
      "medianReviewDays": 78
    },
    {
      "code": "DYH",
      "deviceName": "Adhesive, Bracket And Tooth Conditioner, Resin",
      "clearances": 4,
      "latest": "2011-09-07",
      "medianReviewDays": 82
    },
    {
      "code": "MVL",
      "deviceName": "Cord, Retraction",
      "clearances": 4,
      "latest": "2015-09-24",
      "medianReviewDays": 66
    },
    {
      "code": "DYW",
      "deviceName": "Bracket, Plastic, Orthodontic",
      "clearances": 3,
      "latest": "2007-05-03",
      "medianReviewDays": 17
    },
    {
      "code": "EFB",
      "deviceName": "Handpiece, Air-Powered, Dental",
      "clearances": 1,
      "latest": "1999-10-13",
      "medianReviewDays": 89
    },
    {
      "code": "EFS",
      "deviceName": "Unit, Oral Irrigation",
      "clearances": 1,
      "latest": "1997-02-10",
      "medianReviewDays": 73
    },
    {
      "code": "EIG",
      "deviceName": "Retractor, All Types",
      "clearances": 1,
      "latest": "1997-06-03",
      "medianReviewDays": 57
    },
    {
      "code": "EIH",
      "deviceName": "Powder, Porcelain",
      "clearances": 1,
      "latest": "1995-05-10",
      "medianReviewDays": 34
    },
    {
      "code": "EJI",
      "deviceName": "Syringe, Cartridge",
      "clearances": 1,
      "latest": "1994-10-21",
      "medianReviewDays": 100
    },
    {
      "code": "ELW",
      "deviceName": "Material, Impression",
      "clearances": 1,
      "latest": "1994-05-27",
      "medianReviewDays": 93
    },
    {
      "code": "JES",
      "deviceName": "Floss, Dental",
      "clearances": 1,
      "latest": "1992-06-16",
      "medianReviewDays": 74
    },
    {
      "code": "KOJ",
      "deviceName": "Airbrush",
      "clearances": 1,
      "latest": "1998-05-12",
      "medianReviewDays": 77
    },
    {
      "code": "LFC",
      "deviceName": "Device, Caries Detection",
      "clearances": 1,
      "latest": "1995-09-05",
      "medianReviewDays": 40
    },
    {
      "code": "LYC",
      "deviceName": "Bone Grafting Material, Synthetic",
      "clearances": 1,
      "latest": "2005-07-19",
      "medianReviewDays": 300
    }
  ],
  "productCodesShown": 22,
  "productCodesTotal": "22",
  "recentClearances": [
    {
      "kNumber": "K262228",
      "deviceName": "Transcend Bulk Fill Flowable Composite",
      "productCode": "EBF",
      "decisionDate": "2026-07-01",
      "reviewDays": 1
    },
    {
      "kNumber": "K261404",
      "deviceName": "UltraEZ",
      "productCode": "LBH",
      "decisionDate": "2026-04-30",
      "reviewDays": 1
    },
    {
      "kNumber": "K240743",
      "deviceName": "Peak Universal Bond",
      "productCode": "KLE",
      "decisionDate": "2024-03-20",
      "reviewDays": 2
    },
    {
      "kNumber": "K240694",
      "deviceName": "FORMA Composite (Shade A3D)",
      "productCode": "EBF",
      "decisionDate": "2024-03-15",
      "reviewDays": 1
    },
    {
      "kNumber": "K221909",
      "deviceName": "J-Temp",
      "productCode": "EBF",
      "decisionDate": "2022-07-01",
      "reviewDays": 1
    },
    {
      "kNumber": "K220471",
      "deviceName": "VALO X, VALO X Accessory Lenses",
      "productCode": "EBZ",
      "decisionDate": "2022-02-22",
      "reviewDays": 4
    },
    {
      "kNumber": "K211905",
      "deviceName": "UltraCal XS",
      "productCode": "KIF",
      "decisionDate": "2021-10-13",
      "reviewDays": 114
    },
    {
      "kNumber": "K211237",
      "deviceName": "UltraTemp Rez II",
      "productCode": "EMA",
      "decisionDate": "2021-07-13",
      "reviewDays": 78
    },
    {
      "kNumber": "K210550",
      "deviceName": "VALO Grand Corded and Accessory Lenses",
      "productCode": "EBZ",
      "decisionDate": "2021-03-01",
      "reviewDays": 4
    },
    {
      "kNumber": "K190627",
      "deviceName": "VALO Grand Corded",
      "productCode": "EBZ",
      "decisionDate": "2019-04-29",
      "reviewDays": 48
    }
  ],
  "nameVariants": {
    "total": "4",
    "shown": [
      {
        "name": "Ultradent Products Inc.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Ultradent Products, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Ultradent Products, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Ultradent Products, Inc.",
        "dataset": "device/enforcement",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Ultradent%20Products%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Ultradent%20Products%2C%20Inc.%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.044Z"
}
