{
  "code": "KLE",
  "deviceName": "Agent, Tooth Bonding, Resin",
  "deviceClass": "II",
  "regulationNumber": "872.3200",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 419,
    "last12Months": 8
  },
  "adverseEvents": {
    "total": 32,
    "last12Months": 13
  },
  "reviewDays": {
    "median": 70,
    "sampleSize": 419
  },
  "recalls": {
    "total": 20,
    "recent": [
      {
        "resNumber": "Z-0797-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "3M Unitek Corporation",
        "firmAsPublished": "3M Unitek Corporation",
        "reason": "Due to an increase of complaints for bracket bond failures and skin irritation or blistering.",
        "initiated": "2024-11-26"
      },
      {
        "resNumber": "Z-1368-2022",
        "status": "Completed",
        "recallClass": "Class II",
        "firm": "Ultradent Products, Inc.",
        "firmAsPublished": "Ultradent Products, Inc.",
        "reason": "SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.",
        "initiated": "2022-06-01"
      },
      {
        "resNumber": "Z-0741-2018",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Cosmedent, Inc.",
        "firmAsPublished": "Cosmedent, Inc.",
        "reason": "Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.",
        "initiated": "2017-09-28"
      },
      {
        "resNumber": "Z-0955-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Voco GmbH",
        "firmAsPublished": "Voco GmbH",
        "reason": "Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.",
        "initiated": "2016-11-03"
      },
      {
        "resNumber": "Z-2128-2014",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Novocol, Inc.",
        "firmAsPublished": "Novocol, Inc.",
        "reason": "Septodont is recalling Self-Etch bond because the material was incorrectly packaged.",
        "initiated": "2014-07-16"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260485",
      "deviceName": "Any-Etch",
      "applicant": "Mediclus Co., Ltd.",
      "company": "Mediclus Co., Ltd.",
      "decisionDate": "2026-05-14",
      "dateReceived": "2026-02-13"
    },
    {
      "kNumber": "K260430",
      "deviceName": "Porcelain Etch Gel",
      "applicant": "Belport Company, Inc., Gingi-Pak",
      "company": "Belport Company, Inc., Gingi-Pak",
      "decisionDate": "2026-04-10",
      "dateReceived": "2026-02-10"
    },
    {
      "kNumber": "K252450",
      "deviceName": "Adhese 2",
      "applicant": "Ivoclar Vivadent, Inc.",
      "company": "Ivoclar Vivadent, Inc.",
      "decisionDate": "2026-03-05",
      "dateReceived": "2025-08-04"
    },
    {
      "kNumber": "K260682",
      "deviceName": "Bond-PR™ Universal Adhesive",
      "applicant": "Premier Dental Products Company",
      "company": "Premier Dental Products Co",
      "decisionDate": "2026-03-03",
      "dateReceived": "2026-03-02"
    },
    {
      "kNumber": "K251587",
      "deviceName": "VITA VMLC Primer",
      "applicant": "Vita Zahnfabrik H. Rauter GmbH & Co. Kg.",
      "company": "Vita Zahnfabrik H. Rauter GmbH & Co. Kg.",
      "decisionDate": "2026-02-23",
      "dateReceived": "2025-05-23"
    },
    {
      "kNumber": "K252151",
      "deviceName": "els unibond",
      "applicant": "Saremco Dental AG",
      "company": "Saremco Dental AG",
      "decisionDate": "2025-12-05",
      "dateReceived": "2025-07-09"
    },
    {
      "kNumber": "K252469",
      "deviceName": "MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA",
      "applicant": "Dmp Dental Industry S.A.",
      "company": "Dmp Dental Industry S.A.",
      "decisionDate": "2025-11-06",
      "dateReceived": "2025-08-06"
    },
    {
      "kNumber": "K251124",
      "deviceName": "G-Bond Universal",
      "applicant": "GC America, Inc.",
      "company": "GC America, Inc.",
      "decisionDate": "2025-10-02",
      "dateReceived": "2025-04-11"
    },
    {
      "kNumber": "K242530",
      "deviceName": "HF-Etchant Hydrofluoric Acid Etching Gel",
      "applicant": "Rizhao Huge Biomaterials Company, Ltd.",
      "company": "Rizhao Huge Biomaterials Company, Ltd.",
      "decisionDate": "2024-12-20",
      "dateReceived": "2024-08-26"
    },
    {
      "kNumber": "K242749",
      "deviceName": "TopCEM Ceramic Primer Ceramic Coupling Agent",
      "applicant": "Rizhao Huge Biomaterials Company, Ltd.",
      "company": "Rizhao Huge Biomaterials Company, Ltd.",
      "decisionDate": "2024-11-08",
      "dateReceived": "2024-09-12"
    }
  ],
  "topApplicants": [
    {
      "name": "Dentsply Intl.",
      "count": 20
    },
    {
      "name": "Ultradent Products, Inc.",
      "count": 19
    },
    {
      "name": "Bisco, Inc.",
      "count": 18
    },
    {
      "name": "Heraeus Kulzer, Inc.",
      "count": 16
    },
    {
      "name": "Kuraray Medical, Inc.",
      "count": 14
    }
  ],
  "topCompanies": [
    {
      "name": "Dentsply Intl., Inc.",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "Heraeus Kulzer, LLC.",
      "count": 19,
      "spellings": 3
    },
    {
      "name": "Ultradent Products, Inc.",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Bisco, Inc.",
      "count": 18,
      "spellings": 1
    },
    {
      "name": "Parkell, Inc.",
      "count": 16,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Vita Zahnfabrik H. Rauter GmbH & Co. Kg.",
      "since": "2026-02-23",
      "kNumber": "K251587"
    },
    {
      "name": "Saremco Dental AG",
      "since": "2025-12-05",
      "kNumber": "K252151"
    },
    {
      "name": "Dmp Dental Industry S.A.",
      "since": "2025-11-06",
      "kNumber": "K252469"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "KLE (Agent, Tooth Bonding, Resin) has two findings, most consequential first. 3 first-time filers in the last 12 months, including Vita Zahnfabrik H. Rauter GmbH & Co. Kg. and Saremco Dental AG (K251587, K252151, K252469). The code is crowded, scoring 85 of 100 — 126 companies hold a clearance here and 8 arrived in the last 12 months (KLE:crowding).",
    "severity": 43,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Vita Zahnfabrik H. Rauter GmbH & Co. Kg. and Saremco Dental AG",
        "recordIds": [
          "K251587",
          "K252151",
          "K252469"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 85 of 100 — 126 companies hold a clearance here and 8 arrived in the last 12 months",
        "recordIds": [
          "KLE: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%3AKLE"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKLE"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKLE"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKLE"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKLE"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKLE"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKLE"
    }
  ],
  "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": "2026-08-11T13:51:45.732Z"
}