{
  "code": "EIA",
  "deviceName": "Unit, Operative Dental",
  "deviceClass": "I",
  "regulationNumber": "872.6640",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 284,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 148,
    "last12Months": 22
  },
  "reviewDays": {
    "median": 88,
    "sampleSize": 284
  },
  "recalls": {
    "total": 4,
    "recent": [
      {
        "resNumber": "Z-2530-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Danville Materials, Inc.",
        "firmAsPublished": "Danville Materials, Inc.",
        "reason": "The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date.  Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.",
        "initiated": "2016-06-24"
      },
      {
        "resNumber": "Z-1576-2014",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "William C. Domb, D.M.D., A Professional Corporation",
        "firmAsPublished": "William C. Domb, D.M.D., A Professional Corporation",
        "reason": "William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.",
        "initiated": "2014-04-23"
      },
      {
        "resNumber": "Z-0545-2014",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "ASI Medical, Inc.",
        "firmAsPublished": "ASI Medical, Inc.",
        "reason": "ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.",
        "initiated": "2013-11-05"
      },
      {
        "resNumber": "Z-1177-2012",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Pelton & Crane Company",
        "firmAsPublished": "Pelton & Crane Company",
        "reason": "Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up.",
        "initiated": "2012-02-20"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K251626",
      "deviceName": "Midmark Dental Delivery System",
      "applicant": "Midmark Corporation",
      "company": "Midmark  Corp dba Progeny Inc",
      "decisionDate": "2025-11-03",
      "dateReceived": "2025-05-28"
    },
    {
      "kNumber": "K251491",
      "deviceName": "K5 Cart, K5 Mount, K5 Swing",
      "applicant": "Osstem Implant Company., Ltd. Chair Business",
      "company": "Osstem Implant Company., Ltd. Chair Business",
      "decisionDate": "2025-07-17",
      "dateReceived": "2025-05-14"
    },
    {
      "kNumber": "K243130",
      "deviceName": "Integral Dental Unit",
      "applicant": "Guangdong Yadeng Medical Apparatus Co., Ltd.,",
      "company": "Guangdong Yadeng Medical Apparatus Co., Ltd.,",
      "decisionDate": "2025-06-27",
      "dateReceived": "2024-09-30"
    },
    {
      "kNumber": "K242611",
      "deviceName": "Integral Dental Units",
      "applicant": "Mipont Medical Equipment Co., Ltd.",
      "company": "Mipont Medical Equipment Co., Ltd.",
      "decisionDate": "2025-05-27",
      "dateReceived": "2024-09-03"
    },
    {
      "kNumber": "K250473",
      "deviceName": "Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus",
      "applicant": "Dci International, LLC",
      "company": "Dci International, LLC",
      "decisionDate": "2025-02-19",
      "dateReceived": "2025-02-19"
    },
    {
      "kNumber": "K242404",
      "deviceName": "BDC Dental Unit",
      "applicant": "Bdc Dental Corporation , Ltd.",
      "company": "Bdc Dental Corporation , Ltd.",
      "decisionDate": "2025-02-07",
      "dateReceived": "2024-08-13"
    },
    {
      "kNumber": "K231297",
      "deviceName": "Firstar Dental Unit",
      "applicant": "Firstar Dental Company",
      "company": "Firstar Dental Company",
      "decisionDate": "2025-01-27",
      "dateReceived": "2023-05-04"
    },
    {
      "kNumber": "K233805",
      "deviceName": "K5",
      "applicant": "Osstem Implant Co., Ltd. Chair Business",
      "company": "Osstem Implant Co., Ltd. Chair Business",
      "decisionDate": "2024-09-03",
      "dateReceived": "2023-11-29"
    },
    {
      "kNumber": "K240754",
      "deviceName": "N2",
      "applicant": "Megagen Implant Co., Ltd.",
      "company": "Megagen Implant Co., Ltd.",
      "decisionDate": "2024-03-21",
      "dateReceived": "2024-03-20"
    },
    {
      "kNumber": "K231845",
      "deviceName": "Dental unit Model: Mare",
      "applicant": "Foshan Safety Medical Equipment Co., Ltd.",
      "company": "Foshan Safety Medical Equipment Co., Ltd.",
      "decisionDate": "2024-02-28",
      "dateReceived": "2023-06-22"
    }
  ],
  "topApplicants": [
    {
      "name": "A-Dec, Inc.",
      "count": 25
    },
    {
      "name": "Aseptico, Inc.",
      "count": 5
    },
    {
      "name": "Ace Surgical Supply Co., Inc.",
      "count": 4
    },
    {
      "name": "Air Techniques, Inc.",
      "count": 4
    },
    {
      "name": "Scitech Solutions, Inc.",
      "count": 4
    }
  ],
  "topCompanies": [
    {
      "name": "A-dec, Inc.",
      "count": 25,
      "spellings": 1
    },
    {
      "name": "Aseptico, Inc.",
      "count": 5,
      "spellings": 1
    },
    {
      "name": "Pelton & Crane Company",
      "count": 5,
      "spellings": 2
    },
    {
      "name": "Ace Surgical Supply Co., Inc.",
      "count": 4,
      "spellings": 1
    },
    {
      "name": "Air Techniques, Inc.",
      "count": 4,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "EIA (Unit, Operative Dental): 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%3AEIA"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEIA"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEIA"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEIA"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEIA"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEIA"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEIA"
    }
  ],
  "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": "2026-08-11T13:51:45.692Z"
}