{
  "code": "LYC",
  "deviceName": "Bone Grafting Material, Synthetic",
  "deviceClass": "II",
  "regulationNumber": "872.3930",
  "panel": "Dental",
  "definition": "A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 231,
    "last12Months": 5
  },
  "adverseEvents": {
    "total": 15,
    "last12Months": 1
  },
  "reviewDays": {
    "median": 104,
    "sampleSize": 231
  },
  "recalls": {
    "total": 14,
    "recent": [
      {
        "resNumber": "Z-0414-2019",
        "status": "Terminated",
        "recallClass": "Class III",
        "firm": "Collagen Matrix, Inc.",
        "firmAsPublished": "Collagen Matrix, Inc.",
        "reason": "There is a possibility that the product was packaged in the wrong\nbox. Specifically, the product may have been placed inside a BioMend box instead of a\nBioMend Extend box. The only difference between the two boxes is the\nproduct trade name. The label placed on the box and on the product packaged inside the box is\ncorrect. The Instructions for Use inside the box are correct.",
        "initiated": "2018-08-16"
      },
      {
        "resNumber": "Z-0113-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Osteogenics Biomedical, Inc.",
        "firmAsPublished": "Osteogenics Biomedical, Inc.",
        "reason": "The device has the potential to be packaged in the wrong product box.",
        "initiated": "2016-09-07"
      },
      {
        "resNumber": "Z-0788-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Biomet France SARL",
        "firmAsPublished": "Biomet France SARL",
        "reason": "Cytotoxicity tests were not passed at 36 months.  Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.",
        "initiated": "2016-01-21"
      },
      {
        "resNumber": "Z-1233-2014",
        "status": "Terminated",
        "recallClass": "Class III",
        "firm": "Biomet 3i, LLC",
        "firmAsPublished": "Biomet 3i, LLC",
        "reason": "Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.",
        "initiated": "2013-10-03"
      },
      {
        "resNumber": "Z-1298-2013",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corporation",
        "firmAsPublished": "Integra LifeSciences Corporation",
        "reason": "Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.",
        "initiated": "2013-03-28"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253317",
      "deviceName": "Cytrans™ Elashield",
      "applicant": "GC America, Inc.",
      "company": "GC America, Inc.",
      "decisionDate": "2026-07-06",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K253883",
      "deviceName": "Bonalive Maxillofacial",
      "applicant": "Bonalive , Ltd.",
      "company": "Bonalive , Ltd.",
      "decisionDate": "2026-05-14",
      "dateReceived": "2025-12-04"
    },
    {
      "kNumber": "K251818",
      "deviceName": "BONTREE PLUS",
      "applicant": "Hudens Bio Co., Ltd.",
      "company": "Hudens Bio Co., Ltd.",
      "decisionDate": "2026-03-06",
      "dateReceived": "2025-06-13"
    },
    {
      "kNumber": "K244006",
      "deviceName": "FG Bone Graft M",
      "applicant": "Full Golden Biotech Co., Ltd.",
      "company": "Full Golden Biotech Corporation",
      "decisionDate": "2025-09-17",
      "dateReceived": "2024-12-26"
    },
    {
      "kNumber": "K243745",
      "deviceName": "FG Bone Graft B",
      "applicant": "Full Golden Biotech Corporation",
      "company": "Full Golden Biotech Corporation",
      "decisionDate": "2025-08-29",
      "dateReceived": "2024-12-05"
    },
    {
      "kNumber": "K241186",
      "deviceName": "Synthetic Bone Graft Particulate",
      "applicant": "Shenzhen Dazhou Medical Technology Co., Ltd.",
      "company": "Shenzhen Dazhou Medical Technology Co., Ltd.",
      "decisionDate": "2025-02-21",
      "dateReceived": "2024-04-29"
    },
    {
      "kNumber": "K213260",
      "deviceName": "CMFlexTM",
      "applicant": "Dimension Inx Corp.",
      "company": "Dimension Inx Corp.",
      "decisionDate": "2022-12-30",
      "dateReceived": "2021-09-30"
    },
    {
      "kNumber": "K202675",
      "deviceName": "InRoad® Dental Synthetic Bone Graft",
      "applicant": "Osteogene Tech Corp",
      "company": "Osteogene Tech Corp",
      "decisionDate": "2022-03-04",
      "dateReceived": "2020-09-15"
    },
    {
      "kNumber": "K201546",
      "deviceName": "OsOpia Synthetic Bone Void Filler",
      "applicant": "Revisios BV",
      "company": "Revisios BV",
      "decisionDate": "2020-10-02",
      "dateReceived": "2020-06-09"
    },
    {
      "kNumber": "K201051",
      "deviceName": "Straumann BoneCeramic",
      "applicant": "Institut Straumann AG",
      "company": "Institut Straumann AG",
      "decisionDate": "2020-09-24",
      "dateReceived": "2020-04-21"
    }
  ],
  "topApplicants": [
    {
      "name": "Bio-Interfaces, Inc.",
      "count": 15
    },
    {
      "name": "Ceramed Corp.",
      "count": 13
    },
    {
      "name": "Geistlich-Pharma",
      "count": 11
    },
    {
      "name": "Novabone Products, LLC",
      "count": 9
    },
    {
      "name": "Coors Biomedical Co.",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "Bio-Interfaces, Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Ceramed Corp.",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Geistlich Pharma AG",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Novabone Products, LLC",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Unicare Biomedical, Inc.",
      "count": 7,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Bonalive , Ltd.",
      "since": "2026-05-14",
      "kNumber": "K253883"
    },
    {
      "name": "Hudens Bio Co., Ltd.",
      "since": "2026-03-06",
      "kNumber": "K251818"
    },
    {
      "name": "Full Golden Biotech Corporation",
      "since": "2025-08-29",
      "kNumber": "K243745"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-03-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "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": "LYC (Bone Grafting Material, Synthetic) has two findings, most consequential first. 3 first-time filers in the last 12 months, including Bonalive , Ltd. and Hudens Bio Co., Ltd (K253883, K251818, K243745). The code is crowded, scoring 80 of 100 — 107 companies hold a clearance here and 5 arrived in the last 12 months (LYC:crowding).",
    "severity": 43,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Bonalive , Ltd. and Hudens Bio Co., Ltd.",
        "recordIds": [
          "K253883",
          "K251818",
          "K243745"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 80 of 100 — 107 companies hold a clearance here and 5 arrived in the last 12 months",
        "recordIds": [
          "LYC: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%3ALYC"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALYC"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALYC"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALYC"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALYC"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALYC"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALYC"
    }
  ],
  "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": "2026-08-11T13:51:45.741Z"
}