{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "St Pete Beach",
      "advisory_committee_description": "Unknown",
      "address_1": "5820 Bali Way S",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "OBR",
      "openfda": {
        "registration_number": [
          "",
          "3001237145",
          "3015525101",
          "3004727093",
          "3020749939",
          "3013652641",
          "3010767848",
          "3027283275",
          "3029507159",
          "3015128224",
          "3011547262",
          "3008763803",
          "3011545201",
          "3006789197",
          "3003283852",
          "3008808560",
          "3017968320",
          "3030268763",
          "3028271666",
          "3019729646",
          "1833025",
          "1723435",
          "3009133124",
          "3017575849",
          "2529596",
          "2938386",
          "3002911411",
          "1825660",
          "3008808087",
          "3010358861",
          "1818945",
          "3007336881",
          "3039524192",
          "1719513",
          "3029913483",
          "3011545197"
        ],
        "fei_number": [
          "",
          "3001237145",
          "3015525101",
          "3004727093",
          "3020749939",
          "3013652641",
          "3010767848",
          "3027283275",
          "3029507159",
          "3015128224",
          "3011547262",
          "3008763803",
          "3011545201",
          "3006789197",
          "3003283852",
          "3030268763",
          "3017968320",
          "3028271666",
          "3019729646",
          "1833025",
          "3009133124",
          "3017575849",
          "3004601847",
          "1000121324",
          "2938386",
          "3000203342",
          "3002911411",
          "1825660",
          "3008808087",
          "3010358861",
          "1818945",
          "3007336881",
          "3039524192",
          "1719513",
          "3029913483",
          "3011545197"
        ],
        "device_name": "Mouthguard, Over-The-Counter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      },
      "zip_code": "33706",
      "applicant": "Boyd Research, Inc.",
      "decision_date": "2021-09-17",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "NTI ClenchGuard",
      "advisory_committee": "",
      "contact": "James  Boyd",
      "expedited_review_flag": "",
      "k_number": "K211158",
      "state": "FL",
      "date_received": "2021-04-19",
      "review_advisory_committee": "DE",
      "postal_code": "33706",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}