{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-19",
    "results": {
      "skip": 0,
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  "results": [
    {
      "pma_number": "P040013",
      "supplement_number": "S018",
      "applicant": "Lynch Biologics, LLC",
      "street_1": "5526 Joseph St.",
      "street_2": "",
      "city": "Franklin",
      "state": "TN",
      "zip": "37064",
      "zip_ext": "",
      "generic_name": "Bone grafting material, dental, with biologic component",
      "trade_name": "GEM 21S (GROWTH-FACTOR ENHANCED MATRIX)",
      "product_code": "NPZ",
      "advisory_committee": "DE",
      "advisory_committee_description": "Dental",
      "supplement_type": "Special (Immediate Track)",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2012-02-29",
      "decision_date": "2014-07-11",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE REVISION OF THE GEM 21S PACKAGE INSERT.",
      "openfda": {
        "registration_number": [
          "3008816891",
          "3003120897",
          "1030489",
          "3018094310",
          "3011175224",
          "1423662",
          "3007884119"
        ],
        "fei_number": [
          "3000215273",
          "3008816891",
          "1000477302",
          "3018094310",
          "3011175224",
          "3003120897",
          "3007884119"
        ],
        "device_name": "Bone Grafting Material, Dental, With Biologic Component",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.3930",
        "device_class": "3"
      }
    }
  ]
}