{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "SHI",
      "openfda": {
        "k_number": [
          "K251926",
          "K251724"
        ],
        "registration_number": [
          "3017575849",
          "3020749939"
        ],
        "fei_number": [
          "3017575849",
          "3020749939"
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      },
      "review_panel": "DE",
      "medical_specialty": "DE",
      "device_name": "Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Dental",
      "device_class": "2",
      "definition": "An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards.",
      "regulation_number": "872.3660",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}