{
  "code": "EBF",
  "deviceName": "Material, Tooth Shade, Resin",
  "deviceClass": "II",
  "regulationNumber": "872.3690",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 934,
    "last12Months": 19
  },
  "adverseEvents": {
    "total": 11,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 69,
    "sampleSize": 934
  },
  "recalls": {
    "total": 69,
    "recent": [
      {
        "resNumber": "Z-3066-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ultradent Products, Inc.",
        "firmAsPublished": "Ultradent Products, Inc.",
        "reason": "Due to a manufacturing issue, red particulates present in the expressed composite.",
        "initiated": "2024-08-02"
      },
      {
        "resNumber": "Z-3067-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ultradent Products, Inc.",
        "firmAsPublished": "Ultradent Products, Inc.",
        "reason": "Due to a manufacturing issue, red particulates present in the expressed composite.",
        "initiated": "2024-08-02"
      },
      {
        "resNumber": "Z-3068-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ultradent Products, Inc.",
        "firmAsPublished": "Ultradent Products, Inc.",
        "reason": "Due to a manufacturing issue, red particulates present in the expressed composite.",
        "initiated": "2024-08-02"
      },
      {
        "resNumber": "Z-0053-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ultradent Products, Inc.",
        "firmAsPublished": "Ultradent Products, Inc.",
        "reason": "Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.",
        "initiated": "2020-08-31"
      },
      {
        "resNumber": "Z-0028-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Voco GmbH",
        "firmAsPublished": "Voco GmbH",
        "reason": "The metal cannula are potentially too loose and may become loose when applying the filing material.",
        "initiated": "2019-07-09"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K262228",
      "deviceName": "Transcend Bulk Fill Flowable Composite",
      "applicant": "Ultradent Products, Inc.",
      "company": "Ultradent Products, Inc.",
      "decisionDate": "2026-07-01",
      "dateReceived": "2026-06-30"
    },
    {
      "kNumber": "K261485",
      "deviceName": "Tetric plus Fill;Tetric plus Flow",
      "applicant": "Ivoclar Vivadent, Inc.",
      "company": "Ivoclar Vivadent, Inc.",
      "decisionDate": "2026-07-01",
      "dateReceived": "2026-05-05"
    },
    {
      "kNumber": "K261246",
      "deviceName": "SRGC-06",
      "applicant": "GC America, Inc.",
      "company": "GC America, Inc.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2026-04-16"
    },
    {
      "kNumber": "K261093",
      "deviceName": "DIAFIL",
      "applicant": "DiaDent Group International",
      "company": "DiaDent Group International",
      "decisionDate": "2026-06-02",
      "dateReceived": "2026-04-02"
    },
    {
      "kNumber": "K261071",
      "deviceName": "DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)",
      "applicant": "DiaDent Group International",
      "company": "DiaDent Group International",
      "decisionDate": "2026-05-19",
      "dateReceived": "2026-04-01"
    },
    {
      "kNumber": "K260805",
      "deviceName": "Dual Core",
      "applicant": "Vericom Co., Ltd.",
      "company": "Vericom Co., Ltd.",
      "decisionDate": "2026-05-11",
      "dateReceived": "2026-03-12"
    },
    {
      "kNumber": "K261357",
      "deviceName": "Grandio disc multicolor",
      "applicant": "Voco GmbH",
      "company": "Voco GmbH",
      "decisionDate": "2026-04-27",
      "dateReceived": "2026-04-24"
    },
    {
      "kNumber": "K261356",
      "deviceName": "Dura-Crown",
      "applicant": "Hangzhou SHINING3D Dental Technology Co., Ltd.",
      "company": "Hangzhou SHINING3D Dental Technology Co., Ltd.",
      "decisionDate": "2026-04-27",
      "dateReceived": "2026-04-24"
    },
    {
      "kNumber": "K260152",
      "deviceName": "Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)",
      "applicant": "Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.",
      "company": "Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.",
      "decisionDate": "2026-04-23",
      "dateReceived": "2026-01-20"
    },
    {
      "kNumber": "K260661",
      "deviceName": "Midas Restore",
      "applicant": "Sprintray, Inc.",
      "company": "Sprintray, Inc.",
      "decisionDate": "2026-04-15",
      "dateReceived": "2026-03-02"
    }
  ],
  "topApplicants": [
    {
      "name": "Voco GmbH",
      "count": 45
    },
    {
      "name": "Bisco, Inc.",
      "count": 30
    },
    {
      "name": "Scientific Pharmaceuticals, Inc.",
      "count": 29
    },
    {
      "name": "Dentsply Intl.",
      "count": 28
    },
    {
      "name": "Ivoclar North America, Inc.",
      "count": 28
    }
  ],
  "topCompanies": [
    {
      "name": "Voco GmbH",
      "count": 45,
      "spellings": 1
    },
    {
      "name": "Bisco, Inc.",
      "count": 30,
      "spellings": 1
    },
    {
      "name": "Pulpdent Corporation",
      "count": 29,
      "spellings": 2
    },
    {
      "name": "Scientific Pharmaceuticals, Inc.",
      "count": 29,
      "spellings": 1
    },
    {
      "name": "Dentsply Intl., Inc.",
      "count": 28,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.",
      "since": "2026-04-23",
      "kNumber": "K260152"
    },
    {
      "name": "New Stetic, SA",
      "since": "2026-03-03",
      "kNumber": "K254245"
    },
    {
      "name": "Hangzhou SHINING3D Dental Technology Co., Ltd.",
      "since": "2025-09-23",
      "kNumber": "K253053"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "EBF (Material, Tooth Shade, Resin) has three findings, most consequential first. 3 first-time filers in the last 12 months, including Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. and New Stetic, SA (K260152, K254245, K253053). Clearances are running 30% faster — a median 48 days over the last 12 months against 69 days all-time (elapsed calendar days, not FDA review days) (EBF:review_time:12m). The code is crowded, scoring 94 of 100 — 219 companies hold a clearance here and 19 arrived in the last 12 months (EBF:crowding).",
    "severity": 43,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. and New Stetic, SA",
        "recordIds": [
          "K260152",
          "K254245",
          "K253053"
        ],
        "severity": 43
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 30% faster — a median 48 days over the last 12 months against 69 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "EBF:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 94 of 100 — 219 companies hold a clearance here and 19 arrived in the last 12 months",
        "recordIds": [
          "EBF: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%3AEBF"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEBF"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEBF"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEBF"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEBF"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEBF"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEBF"
    }
  ],
  "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": "2026-08-11T13:51:45.689Z"
}