{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "has_donation_id_number": "true",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "KN95 Earloop Face Mask 10/Pk",
      "public_device_record_key": "3a235a91-7a1f-497b-bba1-70206ca52083",
      "has_serial_number": "true",
      "public_version_date": "2026-03-13",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "080194935",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00817169029649",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "true",
      "version_or_model_number": "M-KN95",
      "has_manufacturing_date": "true",
      "brand_name": "Essentials By 3D Dental",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "MSH",
          "name": "Respirator, Surgical",
          "openfda": {
            "device_name": "Respirator, Surgical",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4040",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "true",
      "company_name": "3D DENTAL DESIGNS AND DEVELOPMENT, LLC",
      "public_version_status": "New",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "57794",
          "name": "Surgical/medical respirator, non-antimicrobial, single-use",
          "definition": "A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2026-03-05"
    }
  ]
}