{
  "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": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Santa Ana",
      "advisory_committee_description": "Dental",
      "address_1": "1520 Brookhollow Dr.",
      "address_2": "Suite 38",
      "statement_or_summary": "Summary",
      "product_code": "SHI",
      "openfda": {
        "device_name": "Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.3660",
        "device_class": "2",
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      "applicant": "Encore Guards",
      "decision_date": "2026-03-17",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "enCore Impression Material",
      "advisory_committee": "DE",
      "contact": "Benjamin  Li",
      "expedited_review_flag": "",
      "k_number": "K251926",
      "state": "CA",
      "date_received": "2025-06-23",
      "review_advisory_committee": "DE",
      "postal_code": "92705",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}