{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Cristaline Aligners",
        "Sigma Aligners"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3035691085",
        "fei_number": "3035691085",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "CRISTALINE ALIGNERS GMBH",
        "address_line_1": "Hanauer Strasse 1-5",
        "address_line_2": "",
        "city": "Pforzheim Baden-Wurttemberg",
        "state_code": "",
        "iso_country_code": "DE",
        "zip_code": "",
        "postal_code": "75181",
        "us_agent": {
          "name": "Patsy Trisler",
          "business_name": "Trisler Consulting dba",
          "bus_phone_area_code": "301",
          "bus_phone_num": "7855597",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "trisconsult@icloud.com",
          "address_line_1": "306 Turnberry Ct",
          "address_line_2": "",
          "city": "Lebanon",
          "state_code": "IN",
          "iso_country_code": "US",
          "zip_code": "46052",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Cristaline Aligners GmbH",
          "owner_operator_number": "10092474",
          "official_correspondent": {
            "first_name": "Patsy",
            "middle_initial": "J",
            "last_name": "Trisler",
            "subaccount_company_name": "",
            "phone_number": "49-723-16084104-x"
          },
          "contact_address": {
            "address_1": "Hanauer Strasse 1-5",
            "address_2": "",
            "city": "Pforzheim",
            "state_code": "DE-BW",
            "state_province": "Baden-Wurttemberg",
            "iso_country_code": "DE",
            "postal_code": "75181"
          }
        }
      },
      "pma_number": "",
      "k_number": "K242892",
      "products": [
        {
          "product_code": "NXC",
          "created_date": "2025-01-12",
          "owner_operator_number": "10092474",
          "exempt": "",
          "openfda": {
            "device_name": "Aligner, Sequential",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.5470",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}