{
  "code": "EFB",
  "deviceName": "Handpiece, Air-Powered, Dental",
  "deviceClass": "I",
  "regulationNumber": "872.4200",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 261,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 312,
    "last12Months": 44
  },
  "reviewDays": {
    "median": 104,
    "sampleSize": 261
  },
  "recalls": {
    "total": 8,
    "recent": [
      {
        "resNumber": "Z-1208-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Coltene /Whaledent AG",
        "firmAsPublished": "Coltene Whaledent Inc",
        "reason": "Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button",
        "initiated": "2023-01-20"
      },
      {
        "resNumber": "Z-2674-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Nakanishi Inc.",
        "firmAsPublished": "Nakanishi Inc.",
        "reason": "Through an error, the labeling failed to include the symbol or other text indicating that the  diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only.\r\n\r\nThis problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.",
        "initiated": "2016-07-08"
      },
      {
        "resNumber": "Z-2044-2014",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "MTI Precision Products LLC.",
        "firmAsPublished": "MTI Precision Products LLC.",
        "reason": "Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.",
        "initiated": "2012-05-07"
      },
      {
        "resNumber": "Z-0289-2007",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Kavo America Corporation",
        "firmAsPublished": "Kavo America Corporation",
        "reason": "The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances.  In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.",
        "initiated": "2006-11-22"
      },
      {
        "resNumber": "Z-0154-04",
        "status": "Terminated",
        "recallClass": null,
        "firm": "DentSply -Professional Division",
        "firmAsPublished": "DentSply -Professional Division",
        "reason": "Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.",
        "initiated": "2003-10-14"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K251389",
      "deviceName": "High speed air turbine handpiece",
      "applicant": "Foshan Topmed Dental Co., Ltd.",
      "company": "Foshan Topmed Dental Co., Ltd.",
      "decisionDate": "2026-01-12",
      "dateReceived": "2025-05-05"
    },
    {
      "kNumber": "K251388",
      "deviceName": "Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)",
      "applicant": "Foshan Topmed Dental Co., Ltd.",
      "company": "Foshan Topmed Dental Co., Ltd.",
      "decisionDate": "2026-01-12",
      "dateReceived": "2025-05-05"
    },
    {
      "kNumber": "K242179",
      "deviceName": "Synea Fusion Handpieces (Intensiv & Profin)",
      "applicant": "W&H Dentalwerk Bürmoos GmbH",
      "company": "W&H Dentalwerk Burmoos GmbH",
      "decisionDate": "2025-02-28",
      "dateReceived": "2024-07-25"
    },
    {
      "kNumber": "K240337",
      "deviceName": "Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)",
      "applicant": "Guangdong Jinme Medical Technology Co., Ltd.",
      "company": "Guangdong Jinme Medical Technology Co., Ltd.",
      "decisionDate": "2024-11-13",
      "dateReceived": "2024-02-05"
    },
    {
      "kNumber": "K241074",
      "deviceName": "High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces:  SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces:  SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)",
      "applicant": "Foshan Soco Precision Instrument Co., Ltd.",
      "company": "Foshan Soco Precision Instrument Co., Ltd.",
      "decisionDate": "2024-11-12",
      "dateReceived": "2024-04-19"
    },
    {
      "kNumber": "K241880",
      "deviceName": "Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)",
      "applicant": "Nakanishi, Inc.",
      "company": "Nakanishi Inc.",
      "decisionDate": "2024-09-20",
      "dateReceived": "2024-06-28"
    },
    {
      "kNumber": "K233122",
      "deviceName": "High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)",
      "applicant": "Litu Tech , Ltd.",
      "company": "Litu Tech , Ltd.",
      "decisionDate": "2024-04-30",
      "dateReceived": "2023-09-27"
    },
    {
      "kNumber": "K233308",
      "deviceName": "Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)",
      "applicant": "Nakanishi, Inc.",
      "company": "Nakanishi Inc.",
      "decisionDate": "2024-04-25",
      "dateReceived": "2023-09-29"
    },
    {
      "kNumber": "K220179",
      "deviceName": "High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors",
      "applicant": "Foshan Coxo Medical Instrument Co., Ltd.",
      "company": "Foshan Coxo Medical Instrument Co., Ltd.",
      "decisionDate": "2023-09-22",
      "dateReceived": "2022-01-21"
    },
    {
      "kNumber": "K232243",
      "deviceName": "EVO 700 series high speed handpiece",
      "applicant": "Ttbio Corp.",
      "company": "TTBIO CORPORATION",
      "decisionDate": "2023-08-23",
      "dateReceived": "2023-07-28"
    }
  ],
  "topApplicants": [
    {
      "name": "A-Dec, Inc.",
      "count": 19
    },
    {
      "name": "Nakanishi, Inc.",
      "count": 10
    },
    {
      "name": "Dentsply Intl.",
      "count": 7
    },
    {
      "name": "Micro Motors, Inc.",
      "count": 7
    },
    {
      "name": "Dentalez, Inc.",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "A-dec, Inc.",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Nakanishi Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Dentsply Intl., Inc.",
      "count": 8,
      "spellings": 2
    },
    {
      "name": "Micro Motors, Inc.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Dentalez, Inc.",
      "count": 6,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Foshan Topmed Dental Co., Ltd.",
      "since": "2026-01-12",
      "kNumber": "K251388"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 30,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 31,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 13,
        "expectedLow": 0,
        "expectedHigh": 16.77913580592849,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 16.668624902592807,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 17.3873366281495,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 15,
        "expectedLow": 0,
        "expectedHigh": 17.023751940585136,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 18.38210418848259,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 18.00343600542821,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 20,
        "expectedLow": 0,
        "expectedHigh": 26.870560597804452,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 7,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "EFB (Handpiece, Air-Powered, Dental) has two findings, most consequential first. 1 first-time filer in the last 12 months, Foshan Topmed Dental Co., Ltd (K251388). The code is crowded, scoring 71 of 100 — 140 companies hold a clearance here and 2 arrived in the last 12 months (EFB:crowding).",
    "severity": 41,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Foshan Topmed Dental Co., Ltd.",
        "recordIds": [
          "K251388"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 71 of 100 — 140 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "EFB: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%3AEFB"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEFB"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEFB"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEFB"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEFB"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEFB"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEFB"
    }
  ],
  "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": "2026-08-11T13:51:45.691Z"
}