{
  "code": "ELC",
  "deviceName": "Scaler, Ultrasonic",
  "deviceClass": "II",
  "regulationNumber": "872.4850",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 195,
    "last12Months": 3
  },
  "adverseEvents": {
    "total": 744,
    "last12Months": 204
  },
  "reviewDays": {
    "median": 90,
    "sampleSize": 195
  },
  "recalls": {
    "total": 10,
    "recent": [
      {
        "resNumber": "Z-2177-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Dental EZ Group Star Dental Division",
        "firmAsPublished": "Dental EZ Group Star Dental Division",
        "reason": "Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to\nstay seated in the holder may cause injury",
        "initiated": "2024-05-30"
      },
      {
        "resNumber": "Z-2178-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Dental EZ Group Star Dental Division",
        "firmAsPublished": "Dental EZ Group Star Dental Division",
        "reason": "Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to\nstay seated in the holder may cause injury",
        "initiated": "2024-05-30"
      },
      {
        "resNumber": "Z-1686-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Electro Medical Systems SA",
        "firmAsPublished": "Electro Medical Systems SA",
        "reason": "Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).",
        "initiated": "2024-03-13"
      },
      {
        "resNumber": "Z-1687-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Electro Medical Systems SA",
        "firmAsPublished": "Electro Medical Systems SA",
        "reason": "Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).",
        "initiated": "2024-03-13"
      },
      {
        "resNumber": "Z-1688-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Electro Medical Systems SA",
        "firmAsPublished": "Electro Medical Systems SA",
        "reason": "Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).",
        "initiated": "2024-03-13"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260773",
      "deviceName": "Varios Combi Pro2",
      "applicant": "Nakanishi, Inc.",
      "company": "Nakanishi Inc.",
      "decisionDate": "2026-03-10",
      "dateReceived": "2026-03-09"
    },
    {
      "kNumber": "K253254",
      "deviceName": "GBT Machine Airflow Prophylaxis Master",
      "applicant": "E.M.S Electro Medical Systems S.A",
      "company": "E.M.S. ELECTRO MEDICAL SYSTEMS S.A.",
      "decisionDate": "2026-01-28",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K251689",
      "deviceName": "VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)",
      "applicant": "Nakanishi, Inc.",
      "company": "Nakanishi Inc.",
      "decisionDate": "2025-09-19",
      "dateReceived": "2025-06-02"
    },
    {
      "kNumber": "K242317",
      "deviceName": "Integrated Endo System (Meet Endo-II)",
      "applicant": "Denjoy Dental Co., Ltd.",
      "company": "Denjoy Dental Co., Ltd.",
      "decisionDate": "2025-02-13",
      "dateReceived": "2024-08-05"
    },
    {
      "kNumber": "K233844",
      "deviceName": "OdneClean",
      "applicant": "Odne AG",
      "company": "Odne AG",
      "decisionDate": "2024-08-08",
      "dateReceived": "2023-12-04"
    },
    {
      "kNumber": "K240707",
      "deviceName": "Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)",
      "applicant": "Shenzhen Micro Electric Intelligence Co., Ltd.",
      "company": "Shenzhen Micro Electric Intelligence Co., Ltd.",
      "decisionDate": "2024-07-02",
      "dateReceived": "2024-03-15"
    },
    {
      "kNumber": "K240801",
      "deviceName": "BioSonic US200 Ultrasonic Scaler (60034537)",
      "applicant": "Dent4you AG",
      "company": "Dent4you AG",
      "decisionDate": "2024-07-01",
      "dateReceived": "2024-03-25"
    },
    {
      "kNumber": "K233922",
      "deviceName": "SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG",
      "applicant": "Satelec - Acteon Group",
      "company": "Satelec - Acteon Group",
      "decisionDate": "2024-03-11",
      "dateReceived": "2023-12-13"
    },
    {
      "kNumber": "K223340",
      "deviceName": "EDS Calculus Softener TURBO CR",
      "applicant": "Essential Dental Systems, Inc.",
      "company": "Essential Dental Systems, Inc.",
      "decisionDate": "2023-12-11",
      "dateReceived": "2022-11-01"
    },
    {
      "kNumber": "K230641",
      "deviceName": "Ultrasonic Scaler Tips",
      "applicant": "Guilin Refine Medical Instrument Co., Ltd.",
      "company": "Guilin Refine Medical Instrument Co., Ltd.",
      "decisionDate": "2023-11-21",
      "dateReceived": "2023-03-08"
    }
  ],
  "topApplicants": [
    {
      "name": "Dentsply Intl.",
      "count": 12
    },
    {
      "name": "E.M.S Electro Medical Systems S.A",
      "count": 10
    },
    {
      "name": "Bonart Co., Ltd.",
      "count": 7
    },
    {
      "name": "Litton Dental Products",
      "count": 7
    },
    {
      "name": "Nakanishi, Inc.",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "Dentsply Intl., Inc.",
      "count": 13,
      "spellings": 2
    },
    {
      "name": "E.M.S. ELECTRO MEDICAL SYSTEMS S.A.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Bonart Co., Ltd.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Litton Dental Products",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Nakanishi Inc.",
      "count": 7,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 27,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 22,
        "expectedLow": 7.716167064904762,
        "expectedHigh": 26.725513586725235,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 10,
        "expectedLow": 7.683033712852177,
        "expectedHigh": 24.772231680254258,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 10,
        "expectedLow": 6.0711919715967895,
        "expectedHigh": 26.0198571753167,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 34,
        "expectedLow": 4.067692390066649,
        "expectedHigh": 25.524050615054463,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 28,
        "expectedLow": 5.909000332478418,
        "expectedHigh": 32.8322406101714,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 33,
        "expectedLow": 7.8809001027497105,
        "expectedHigh": 37.59165316169375,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 21,
        "expectedLow": 13.773625075984857,
        "expectedHigh": 66.98210784392042,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 27,
        "expectedLow": 6.066200037840627,
        "expectedHigh": 46.126313821478895,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 22,
        "expectedLow": 7.7421224921993055,
        "expectedHigh": 47.98957876419019,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 32,
        "expectedLow": 5.992194911020559,
        "expectedHigh": 46.06648237573427,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 11,
        "expectedLow": 6.651059131008068,
        "expectedHigh": 43.21011212438703,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 29,
        "expectedLow": 1.719085279637348,
        "expectedHigh": 44.31582713903573,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 28,
        "expectedLow": 4.4001362718917525,
        "expectedHigh": 53.08639984552477,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 24,
        "expectedLow": 3.3483498487286205,
        "expectedHigh": 44.55823721297807,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 35,
        "expectedLow": 5.0545571402493845,
        "expectedHigh": 47.45240052519992,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "ELC (Scaler, Ultrasonic): 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%3AELC"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AELC"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AELC"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AELC"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AELC"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AELC"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AELC"
    }
  ],
  "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"
}