{
  "code": "EBI",
  "deviceName": "Resin, Denture, Relining, Repairing, Rebasing",
  "deviceClass": "II",
  "regulationNumber": "872.3760",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 332,
    "last12Months": 9
  },
  "adverseEvents": {
    "total": 45,
    "last12Months": 1
  },
  "reviewDays": {
    "median": 85,
    "sampleSize": 332
  },
  "recalls": {
    "total": 16,
    "recent": [
      {
        "resNumber": "Z-2090-2025",
        "status": "Completed",
        "recallClass": "Class III",
        "firm": "STRATASYS LTD",
        "firmAsPublished": "STRATASYS LTD",
        "reason": "Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.",
        "initiated": "2024-01-19"
      },
      {
        "resNumber": "Z-2091-2025",
        "status": "Completed",
        "recallClass": "Class III",
        "firm": "STRATASYS LTD",
        "firmAsPublished": "STRATASYS LTD",
        "reason": "Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.",
        "initiated": "2024-01-19"
      },
      {
        "resNumber": "Z-2092-2025",
        "status": "Completed",
        "recallClass": "Class III",
        "firm": "STRATASYS LTD",
        "firmAsPublished": "STRATASYS LTD",
        "reason": "Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.",
        "initiated": "2024-01-19"
      },
      {
        "resNumber": "Z-2093-2025",
        "status": "Completed",
        "recallClass": "Class III",
        "firm": "STRATASYS LTD",
        "firmAsPublished": "STRATASYS LTD",
        "reason": "Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.",
        "initiated": "2024-01-19"
      },
      {
        "resNumber": "Z-2094-2025",
        "status": "Completed",
        "recallClass": "Class III",
        "firm": "STRATASYS LTD",
        "firmAsPublished": "STRATASYS LTD",
        "reason": "Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.",
        "initiated": "2024-01-19"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K262300",
      "deviceName": "Denture Base Resin V2",
      "applicant": "Formlabs Ohio, Inc.",
      "company": "Formlabs Ohio, Inc.",
      "decisionDate": "2026-07-08",
      "dateReceived": "2026-07-07"
    },
    {
      "kNumber": "K261474",
      "deviceName": "DENTCA Tru Flexible",
      "applicant": "Dentca, Inc.",
      "company": "Dentca, Inc.",
      "decisionDate": "2026-07-01",
      "dateReceived": "2026-05-04"
    },
    {
      "kNumber": "K260569",
      "deviceName": "DB 4000 High Impact Denture Base",
      "applicant": "Carbon, Inc.",
      "company": "Carbon, Inc.",
      "decisionDate": "2026-06-02",
      "dateReceived": "2026-02-19"
    },
    {
      "kNumber": "K260376",
      "deviceName": "Denture Base",
      "applicant": "Shandong Huge Dental Material Corporation",
      "company": "Shandong Huge Dental Material Corporation",
      "decisionDate": "2026-05-06",
      "dateReceived": "2026-02-05"
    },
    {
      "kNumber": "K253365",
      "deviceName": "LuxCreo Flexible Partial Denture Resin",
      "applicant": "LuxCreo, Inc.",
      "company": "LuxCreo, Inc.",
      "decisionDate": "2025-11-25",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K253681",
      "deviceName": "TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)",
      "applicant": "Graphy, Inc.",
      "company": "Graphy, Inc.",
      "decisionDate": "2025-11-21",
      "dateReceived": "2025-11-21"
    },
    {
      "kNumber": "K253324",
      "deviceName": "UltraPrint-Dental Denture UV",
      "applicant": "Guangzhou Heygears IMC., Inc.",
      "company": "Guangzhou Heygears IMC., Inc.",
      "decisionDate": "2025-11-20",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K252430",
      "deviceName": "Freeprint® denture flex",
      "applicant": "Detax GmbH",
      "company": "Detax GmbH",
      "decisionDate": "2025-10-30",
      "dateReceived": "2025-08-01"
    },
    {
      "kNumber": "K252035",
      "deviceName": "DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)",
      "applicant": "Kamemizu Chemical Industry Co., Ltd.",
      "company": "Kamemizu Chemical Industry Co., Ltd.",
      "decisionDate": "2025-09-17",
      "dateReceived": "2025-06-30"
    },
    {
      "kNumber": "K250302",
      "deviceName": "Flexible Partial Resin",
      "applicant": "Prismatik Dentalcraft, Inc.",
      "company": "Prismatik Dentalcraft, Inc.",
      "decisionDate": "2025-06-25",
      "dateReceived": "2025-02-03"
    }
  ],
  "topApplicants": [
    {
      "name": "Dentsply Intl.",
      "count": 16
    },
    {
      "name": "GC America, Inc.",
      "count": 12
    },
    {
      "name": "Heraeus Kulzer, Inc.",
      "count": 11
    },
    {
      "name": "Harry J. Bosworth Co.",
      "count": 8
    },
    {
      "name": "Voco GmbH",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Dentsply Intl., Inc.",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Heraeus Kulzer, LLC.",
      "count": 13,
      "spellings": 2
    },
    {
      "name": "GC America, Inc.",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Harry J Bosworth Company",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Voco GmbH",
      "count": 8,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Formlabs Ohio, Inc.",
      "since": "2026-07-08",
      "kNumber": "K262300"
    },
    {
      "name": "Carbon, Inc.",
      "since": "2026-06-02",
      "kNumber": "K260569"
    },
    {
      "name": "LuxCreo, Inc.",
      "since": "2025-11-25",
      "kNumber": "K253365"
    },
    {
      "name": "Guangzhou Heygears IMC., Inc.",
      "since": "2025-11-20",
      "kNumber": "K253324"
    },
    {
      "name": "Detax GmbH",
      "since": "2025-10-30",
      "kNumber": "K252430"
    },
    {
      "name": "Kamemizu Chemical Industry Co., Ltd.",
      "since": "2025-09-17",
      "kNumber": "K252035"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "EBI (Resin, Denture, Relining, Repairing, Rebasing) has two findings, most consequential first. 6 first-time filers in the last 12 months, including Formlabs Ohio, Inc. and Carbon, Inc (K262300, K260569, K253365, K253324, K252430). The code is crowded, scoring 94 of 100 — 164 companies hold a clearance here and 9 arrived in the last 12 months (EBI:crowding).",
    "severity": 46,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "6 first-time filers in the last 12 months, including Formlabs Ohio, Inc. and Carbon, Inc.",
        "recordIds": [
          "K262300",
          "K260569",
          "K253365",
          "K253324",
          "K252430"
        ],
        "severity": 46
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 94 of 100 — 164 companies hold a clearance here and 9 arrived in the last 12 months",
        "recordIds": [
          "EBI: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%3AEBI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEBI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEBI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEBI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEBI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEBI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEBI"
    }
  ],
  "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": "2026-08-11T13:51:45.690Z"
}