{
  "code": "EIH",
  "deviceName": "Powder, Porcelain",
  "deviceClass": "II",
  "regulationNumber": "872.6660",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 485,
    "last12Months": 13
  },
  "adverseEvents": {
    "total": 10,
    "last12Months": 2
  },
  "reviewDays": {
    "median": 87,
    "sampleSize": 485
  },
  "recalls": {
    "total": 35,
    "recent": [
      {
        "resNumber": "Z-2356-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Sagemax Bioceramics, Inc.",
        "firmAsPublished": "Sagemax Bioceramics, Inc.",
        "reason": "Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have  reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.",
        "initiated": "2025-12-11"
      },
      {
        "resNumber": "Z-1703-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ivoclar Vivadent, Inc.",
        "firmAsPublished": "IVOCLAR VIVADENT AG",
        "reason": "Defective blocks may show cracks after sintering\nIf cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration",
        "initiated": "2024-04-05"
      },
      {
        "resNumber": "Z-1704-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ivoclar Vivadent, Inc.",
        "firmAsPublished": "IVOCLAR VIVADENT AG",
        "reason": "Defective blocks may show cracks after sintering\nIf cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration",
        "initiated": "2024-04-05"
      },
      {
        "resNumber": "Z-1705-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ivoclar Vivadent, Inc.",
        "firmAsPublished": "IVOCLAR VIVADENT AG",
        "reason": "Defective blocks may show cracks after sintering\nIf cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration",
        "initiated": "2024-04-05"
      },
      {
        "resNumber": "Z-1706-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ivoclar Vivadent, Inc.",
        "firmAsPublished": "IVOCLAR VIVADENT AG",
        "reason": "Defective blocks may show cracks after sintering\nIf cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration",
        "initiated": "2024-04-05"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261046",
      "deviceName": "Dental Zirconia Blank & Coloring Liquid",
      "applicant": "Hunan Qinghao Puzhong Technology Co., Ltd.",
      "company": "Hunan Qinghao Puzhong Technology Co., Ltd.",
      "decisionDate": "2026-07-17",
      "dateReceived": "2026-03-31"
    },
    {
      "kNumber": "K262195",
      "deviceName": "Dandy Ceramic Stain and Glaze",
      "applicant": "Zima International Inc., dba Dandy",
      "company": "Zima International Inc., dba Dandy",
      "decisionDate": "2026-06-30",
      "dateReceived": "2026-06-29"
    },
    {
      "kNumber": "K260918",
      "deviceName": "Zolid Lunaris",
      "applicant": "Amann Girrbach AG",
      "company": "Amann Girrbach AG",
      "decisionDate": "2026-06-29",
      "dateReceived": "2026-03-19"
    },
    {
      "kNumber": "K260859",
      "deviceName": "Rosetta SM, Rosetta SP",
      "applicant": "Hass Corp.",
      "company": "Hass Corp.",
      "decisionDate": "2026-06-11",
      "dateReceived": "2026-03-16"
    },
    {
      "kNumber": "K253191",
      "deviceName": "DCMhotbond zircon",
      "applicant": "Dental Creativ Management GmbH",
      "company": "Dental Creativ Management GmbH",
      "decisionDate": "2026-05-21",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K260067",
      "deviceName": "Eternal Art Porcelain Powders",
      "applicant": "Shandong Huge Dental Material Corporation",
      "company": "Shandong Huge Dental Material Corporation",
      "decisionDate": "2026-04-09",
      "dateReceived": "2026-01-09"
    },
    {
      "kNumber": "K260370",
      "deviceName": "Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank",
      "applicant": "Bloomden Bioceramics (HuNan) Co., Ltd.",
      "company": "Bloomden Bioceramics (HuNan) Co., Ltd.",
      "decisionDate": "2026-03-30",
      "dateReceived": "2026-02-05"
    },
    {
      "kNumber": "K253953",
      "deviceName": "IPS e.max Zirconia",
      "applicant": "Ivoclar Vivadent, Inc.",
      "company": "Ivoclar Vivadent, Inc.",
      "decisionDate": "2026-03-10",
      "dateReceived": "2025-12-10"
    },
    {
      "kNumber": "K254283",
      "deviceName": "BruxZir® Shaded 16 PLUS",
      "applicant": "Prismatik Dentalcraft, Inc.",
      "company": "Prismatik Dentalcraft, Inc.",
      "decisionDate": "2026-01-30",
      "dateReceived": "2025-12-31"
    },
    {
      "kNumber": "K253973",
      "deviceName": "Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series",
      "applicant": "Liaoning Upcera Co., Ltd.",
      "company": "Liaoning Upcera Co., Ltd.",
      "decisionDate": "2026-01-09",
      "dateReceived": "2025-12-11"
    }
  ],
  "topApplicants": [
    {
      "name": "Dentsply Intl.",
      "count": 23
    },
    {
      "name": "Prismatik Dentalcraft, Inc.",
      "count": 20
    },
    {
      "name": "Vident",
      "count": 16
    },
    {
      "name": "Noritake Co., Inc.",
      "count": 14
    },
    {
      "name": "Wieland Dental + Technik GmbH & Co. KG",
      "count": 14
    }
  ],
  "topCompanies": [
    {
      "name": "Dentsply Intl., Inc.",
      "count": 23,
      "spellings": 1
    },
    {
      "name": "Prismatik Dentalcraft, Inc.",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "Vident",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Shofu Dental Corporation",
      "count": 15,
      "spellings": 2
    },
    {
      "name": "Noritake Co., Inc.",
      "count": 14,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Zima International Inc., dba Dandy",
      "since": "2026-06-30",
      "kNumber": "K262195"
    },
    {
      "name": "Dental Creativ Management GmbH",
      "since": "2026-05-21",
      "kNumber": "K253191"
    },
    {
      "name": "Shandong Huge Dental Material Corporation",
      "since": "2026-04-09",
      "kNumber": "K260067"
    },
    {
      "name": "Denmat Holding, LLC",
      "since": "2025-08-25",
      "kNumber": "K251593"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2024-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "EIH (Powder, Porcelain) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2356-2026). 4 first-time filers in the last 12 months, including Zima International Inc., dba Dandy and Dental Creativ Management GmbH (K262195, K253191, K260067, K251593). The code is crowded, scoring 96 of 100 — 214 companies hold a clearance here and 13 arrived in the last 12 months (EIH:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2356-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "4 first-time filers in the last 12 months, including Zima International Inc., dba Dandy and Dental Creativ Management GmbH",
        "recordIds": [
          "K262195",
          "K253191",
          "K260067",
          "K251593"
        ],
        "severity": 44
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 96 of 100 — 214 companies hold a clearance here and 13 arrived in the last 12 months",
        "recordIds": [
          "EIH:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AEIH"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEIH"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEIH"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEIH"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEIH"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEIH"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEIH"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.692Z"
}