{
  "code": "EJS",
  "deviceName": "Alloy, Other Noble Metal",
  "deviceClass": "II",
  "regulationNumber": "872.3060",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 194,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 0,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 52,
    "sampleSize": 194
  },
  "recalls": {
    "total": 0,
    "recent": []
  },
  "recentClearances": [
    {
      "kNumber": "K041433",
      "deviceName": "BRIGHT GOLD XH",
      "applicant": "Ivoclar Vivadent, Inc.",
      "company": "Ivoclar Vivadent, Inc.",
      "decisionDate": "2004-08-19",
      "dateReceived": "2004-05-28"
    },
    {
      "kNumber": "K040436",
      "deviceName": "SIMIDUR SUPERIOR",
      "applicant": "Wieland Dental + Technik GmbH & Co. KG",
      "company": "Wieland Dental + Technik GmbH & Co. KG",
      "decisionDate": "2004-03-05",
      "dateReceived": "2004-02-19"
    },
    {
      "kNumber": "K022252",
      "deviceName": "STERNGOLD 1, MODEL 1127781",
      "applicant": "Sterngold",
      "company": "Sterngold",
      "decisionDate": "2002-09-19",
      "dateReceived": "2002-07-12"
    },
    {
      "kNumber": "K022469",
      "deviceName": "ECO E4",
      "applicant": "Wieland Dental + Technik GmbH & Co. KG",
      "company": "Wieland Dental + Technik GmbH & Co. KG",
      "decisionDate": "2002-09-18",
      "dateReceived": "2002-07-26"
    },
    {
      "kNumber": "K021367",
      "deviceName": "STERNGOLD 66, MODEL #1180230",
      "applicant": "Sterngold",
      "company": "Sterngold",
      "decisionDate": "2002-05-16",
      "dateReceived": "2002-04-30"
    },
    {
      "kNumber": "K020195",
      "deviceName": "SIMIDUR S1S",
      "applicant": "Wieland Dental + Technik GmbH & Co. KG",
      "company": "Wieland Dental + Technik GmbH & Co. KG",
      "decisionDate": "2002-03-15",
      "dateReceived": "2002-01-22"
    },
    {
      "kNumber": "K020194",
      "deviceName": "SIMIDUR KF PLUS",
      "applicant": "Wieland Dental + Technik GmbH & Co. KG",
      "company": "Wieland Dental + Technik GmbH & Co. KG",
      "decisionDate": "2002-03-15",
      "dateReceived": "2002-01-22"
    },
    {
      "kNumber": "K020192",
      "deviceName": "SIMIDUR S2",
      "applicant": "Wieland Dental + Technik GmbH & Co. KG",
      "company": "Wieland Dental + Technik GmbH & Co. KG",
      "decisionDate": "2002-03-15",
      "dateReceived": "2002-01-22"
    },
    {
      "kNumber": "K014042",
      "deviceName": "D.SIGN 84",
      "applicant": "Ivoclar Vivadent, Inc.",
      "company": "Ivoclar Vivadent, Inc.",
      "decisionDate": "2002-02-22",
      "dateReceived": "2001-12-07"
    },
    {
      "kNumber": "K013809",
      "deviceName": "D.SIGN 59",
      "applicant": "Ivoclar Vivadent, Inc.",
      "company": "Ivoclar Vivadent, Inc.",
      "decisionDate": "2002-02-07",
      "dateReceived": "2001-11-15"
    }
  ],
  "topApplicants": [
    {
      "name": "Metalor Dental USA Corp.",
      "count": 31
    },
    {
      "name": "Deringer-Ney, Inc.",
      "count": 14
    },
    {
      "name": "Ivoclar North America, Inc.",
      "count": 12
    },
    {
      "name": "J.F. Jelenko & Co., Inc.",
      "count": 11
    },
    {
      "name": "Degussa Dental, Inc.",
      "count": 10
    }
  ],
  "topCompanies": [
    {
      "name": "Metalor Dental USA Corp.",
      "count": 31,
      "spellings": 1
    },
    {
      "name": "Deringer-Ney, Inc.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Ivoclar North America, Inc.",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "J.F. Jelenko & Co., Inc.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Degussa Dental, Inc.",
      "count": 10,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "EJS (Alloy, Other 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%3AEJS"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEJS"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEJS"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEJS"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEJS"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEJS"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEJS"
    }
  ],
  "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"
}