{
  "code": "EMA",
  "deviceName": "Cement, Dental",
  "deviceClass": "II",
  "regulationNumber": "872.3275",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 506,
    "last12Months": 10
  },
  "adverseEvents": {
    "total": 19,
    "last12Months": 3
  },
  "reviewDays": {
    "median": 75,
    "sampleSize": 506
  },
  "recalls": {
    "total": 16,
    "recent": [
      {
        "resNumber": "Z-1142-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Voco GmbH",
        "firmAsPublished": "Voco GmbH",
        "reason": "Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.",
        "initiated": "2024-01-25"
      },
      {
        "resNumber": "Z-1143-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Voco GmbH",
        "firmAsPublished": "Voco GmbH",
        "reason": "Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.",
        "initiated": "2024-01-25"
      },
      {
        "resNumber": "Z-0265-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Family Dollar Stores, Llc.",
        "firmAsPublished": "Family Dollar Stores, Llc.",
        "reason": "Products were stored outside of labeled temperature requirements.",
        "initiated": "2023-10-04"
      },
      {
        "resNumber": "Z-1226-2023",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "firm": "Preat Corp",
        "firmAsPublished": "Preat Corp",
        "reason": "Product is labeled with an incorrect expiration date.",
        "initiated": "2023-02-01"
      },
      {
        "resNumber": "Z-1529-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Family Dollar Stores, Llc.",
        "firmAsPublished": "Family Dollar Stores, Llc.",
        "reason": "Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.",
        "initiated": "2022-06-23"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261166",
      "deviceName": "DIA-CEM",
      "applicant": "DiaDent Group International",
      "company": "DiaDent Group International",
      "decisionDate": "2026-07-09",
      "dateReceived": "2026-04-09"
    },
    {
      "kNumber": "K254109",
      "deviceName": "G-CEM UNIVERSAL",
      "applicant": "GC America, Inc.",
      "company": "GC America, Inc.",
      "decisionDate": "2026-05-18",
      "dateReceived": "2025-12-19"
    },
    {
      "kNumber": "K253337",
      "deviceName": "REGEN Bioactive Cement",
      "applicant": "Inter-Med, Inc.",
      "company": "Inter-Med Llc",
      "decisionDate": "2026-04-15",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K252606",
      "deviceName": "Bifix Veneer LC, Bifix Veneer Try-In",
      "applicant": "Voco GmbH",
      "company": "Voco GmbH",
      "decisionDate": "2026-03-20",
      "dateReceived": "2025-08-18"
    },
    {
      "kNumber": "K254063",
      "deviceName": "iCEM Universal Plus",
      "applicant": "Kulzer, LLC",
      "company": "Kulzer, Inc.",
      "decisionDate": "2025-12-19",
      "dateReceived": "2025-12-17"
    },
    {
      "kNumber": "K252785",
      "deviceName": "TopCEM Vigor SA Self-Adhesive Resin Cement",
      "applicant": "Rizhao Huge Biomaterials Company, Ltd.",
      "company": "Rizhao Huge Biomaterials Company, Ltd.",
      "decisionDate": "2025-12-12",
      "dateReceived": "2025-09-02"
    },
    {
      "kNumber": "K252808",
      "deviceName": "GlasIonomer FX-LC",
      "applicant": "Shofu Dental Corporation",
      "company": "Shofu Dental Corporation",
      "decisionDate": "2025-12-09",
      "dateReceived": "2025-09-03"
    },
    {
      "kNumber": "K252165",
      "deviceName": "ZIRCONOMER P",
      "applicant": "Shofu Dental Corporation",
      "company": "Shofu Dental Corporation",
      "decisionDate": "2025-10-28",
      "dateReceived": "2025-07-10"
    },
    {
      "kNumber": "K250953",
      "deviceName": "EQUIA LC ONE",
      "applicant": "GC America, Inc.",
      "company": "GC America, Inc.",
      "decisionDate": "2025-09-19",
      "dateReceived": "2025-03-28"
    },
    {
      "kNumber": "K251775",
      "deviceName": "RODIN Cement",
      "applicant": "Belport Company, Inc., Gingi-Pak",
      "company": "Belport Company, Inc., Gingi-Pak",
      "decisionDate": "2025-09-02",
      "dateReceived": "2025-06-10"
    }
  ],
  "topApplicants": [
    {
      "name": "GC America, Inc.",
      "count": 30
    },
    {
      "name": "Voco GmbH",
      "count": 26
    },
    {
      "name": "Dentsply Intl.",
      "count": 19
    },
    {
      "name": "Shofu Dental Corp.",
      "count": 16
    },
    {
      "name": "3M Company",
      "count": 12
    }
  ],
  "topCompanies": [
    {
      "name": "GC America, Inc.",
      "count": 30,
      "spellings": 1
    },
    {
      "name": "Voco GmbH",
      "count": 26,
      "spellings": 1
    },
    {
      "name": "Shofu Dental Corporation",
      "count": 24,
      "spellings": 2
    },
    {
      "name": "Dentsply Intl., Inc.",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Pulpdent Corporation",
      "count": 14,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Inter-Med Llc",
      "since": "2026-04-15",
      "kNumber": "K253337"
    },
    {
      "name": "Belport Company, Inc., Gingi-Pak",
      "since": "2025-09-02",
      "kNumber": "K251775"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "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": "2023-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "EMA (Cement, Dental) has three findings, most consequential first. 2 first-time filers in the last 12 months, Inter-Med Llc and Belport Company, Inc., Gingi-Pak (K253337, K251775). Clearances are running 35% slower — a median 101 days over the last 12 months against 75 days all-time (elapsed calendar days, not FDA review days) (EMA:review_time:12m). The code is crowded, scoring 86 of 100 — 163 companies hold a clearance here and 10 arrived in the last 12 months (EMA:crowding).",
    "severity": 42,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Inter-Med Llc and Belport Company, Inc., Gingi-Pak",
        "recordIds": [
          "K253337",
          "K251775"
        ],
        "severity": 42
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 35% slower — a median 101 days over the last 12 months against 75 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "EMA:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 86 of 100 — 163 companies hold a clearance here and 10 arrived in the last 12 months",
        "recordIds": [
          "EMA: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%3AEMA"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEMA"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEMA"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEMA"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEMA"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEMA"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEMA"
    }
  ],
  "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": "2026-08-11T13:51:45.694Z"
}