{
  "code": "EJT",
  "deviceName": "Alloy, Gold-Based Noble Metal",
  "deviceClass": "II",
  "regulationNumber": "872.3060",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 627,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 0,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 41,
    "sampleSize": 627
  },
  "recalls": {
    "total": 0,
    "recent": []
  },
  "recentClearances": [
    {
      "kNumber": "K052463",
      "deviceName": "PROMETAL HN86",
      "applicant": "Prometal Technologies",
      "company": "Prometal Technologies",
      "decisionDate": "2005-10-14",
      "dateReceived": "2005-09-08"
    },
    {
      "kNumber": "K041378",
      "deviceName": "BIO 60",
      "applicant": "Kodent, Inc.",
      "company": "Kodent, Inc.",
      "decisionDate": "2004-08-02",
      "dateReceived": "2004-05-24"
    },
    {
      "kNumber": "K040672",
      "deviceName": "PORTA REFLEX",
      "applicant": "Wieland Dental + Technik GmbH & Co. KG",
      "company": "Wieland Dental + Technik GmbH & Co. KG",
      "decisionDate": "2004-05-27",
      "dateReceived": "2004-03-15"
    },
    {
      "kNumber": "K040524",
      "deviceName": "PORTA SOLDER 1090 W",
      "applicant": "Wieland Dental + Technik GmbH & Co. KG",
      "company": "Wieland Dental + Technik GmbH & Co. KG",
      "decisionDate": "2004-05-20",
      "dateReceived": "2004-03-01"
    },
    {
      "kNumber": "K040043",
      "deviceName": "NDX-40 ALLOY",
      "applicant": "Heraeus Kulzer, Inc.",
      "company": "Heraeus Kulzer, LLC.",
      "decisionDate": "2004-03-03",
      "dateReceived": "2004-01-12"
    },
    {
      "kNumber": "K034049",
      "deviceName": "HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM",
      "applicant": "Heraeus Kulzer,GmbH",
      "company": "Heraeus Kulzer, LLC.",
      "decisionDate": "2004-03-01",
      "dateReceived": "2003-12-30"
    },
    {
      "kNumber": "K033279",
      "deviceName": "GOLD DENTAL CASTING ALLOYS",
      "applicant": "Bego U.S.A.",
      "company": "Bego U.S.A.",
      "decisionDate": "2004-01-15",
      "dateReceived": "2003-10-10"
    },
    {
      "kNumber": "K033446",
      "deviceName": "APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82",
      "applicant": "We Dong Myung Dental Industrial Co., Ltd.",
      "company": "We Dong Myung Dental Industrial Co., Ltd.",
      "decisionDate": "2003-11-13",
      "dateReceived": "2003-10-29"
    },
    {
      "kNumber": "K033435",
      "deviceName": "E-SARANG 86, DM78, DM55",
      "applicant": "We Dong Myung Dental Industrial Co., Ltd.",
      "company": "We Dong Myung Dental Industrial Co., Ltd.",
      "decisionDate": "2003-11-12",
      "dateReceived": "2003-10-28"
    },
    {
      "kNumber": "K032320",
      "deviceName": "APPOLLO 3 ALLOY",
      "applicant": "Dentsply International",
      "company": "Dentsply International, Inc.",
      "decisionDate": "2003-10-01",
      "dateReceived": "2003-07-28"
    }
  ],
  "topApplicants": [
    {
      "name": "Argen Precious Metals, Inc.",
      "count": 201
    },
    {
      "name": "J.F. Jelenko & Co., Inc.",
      "count": 38
    },
    {
      "name": "Metalor Dental USA Corp.",
      "count": 31
    },
    {
      "name": "Ivoclar North America, Inc.",
      "count": 29
    },
    {
      "name": "Gateway Alloys, Inc.",
      "count": 27
    }
  ],
  "topCompanies": [
    {
      "name": "Argen Precious Metals, Inc.",
      "count": 201,
      "spellings": 1
    },
    {
      "name": "J.F. Jelenko & Co., Inc.",
      "count": 38,
      "spellings": 1
    },
    {
      "name": "Metalor Dental USA Corp.",
      "count": 31,
      "spellings": 1
    },
    {
      "name": "Ivoclar North America, Inc.",
      "count": 29,
      "spellings": 1
    },
    {
      "name": "Gateway Alloys, Inc.",
      "count": 27,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "EJT (Alloy, Gold-Based Noble Metal): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "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%3AEJT"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEJT"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEJT"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEJT"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEJT"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEJT"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEJT"
    }
  ],
  "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": "2026-08-11T13:51:45.693Z"
}