{
  "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": 13
    }
  },
  "results": [
    {
      "proprietary_name": [
        "DTX Studio Implant"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3005739655",
        "fei_number": "3005739655",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Nobel Biocare c/o Medicim NV",
        "address_line_1": "Stationsstraat 102",
        "address_line_2": "",
        "city": "Mechelen Antwerpen",
        "state_code": "",
        "iso_country_code": "BE",
        "zip_code": "",
        "postal_code": "B-2800",
        "us_agent": {
          "name": "John Sharobiem",
          "business_name": "",
          "bus_phone_area_code": "201",
          "bus_phone_num": "5297103",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "john.sharobiem@envistaco.com",
          "address_line_1": "800 Corporate Dr",
          "address_line_2": "",
          "city": "Mahwah",
          "state_code": "NJ",
          "iso_country_code": "US",
          "zip_code": "07430",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Nobel Biocare Services AG",
          "owner_operator_number": "8030879",
          "official_correspondent": {
            "first_name": "Valeria",
            "middle_initial": "",
            "last_name": "Barbarito",
            "subaccount_company_name": "",
            "phone_number": "41-43-2114200-x"
          },
          "contact_address": {
            "address_1": "Balz-Zimmermann-Strasse 7",
            "address_2": "",
            "city": "Kloten",
            "state_code": "CH-ZH",
            "state_province": "Zurich",
            "iso_country_code": "CH",
            "postal_code": "8302"
          }
        }
      },
      "pma_number": "",
      "k_number": "K163122",
      "products": [
        {
          "product_code": "LLZ",
          "created_date": "2017-02-16",
          "owner_operator_number": "8030879",
          "exempt": "",
          "openfda": {
            "device_name": "System, Image Processing, Radiological",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.2050",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}