{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 14
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Luna Gold",
        "ROEKO Cotton-roll",
        "ROEKO Solomat-N",
        "ROEKO Lunamat",
        "ROEKO Parotisroll",
        "ROEKO Luna",
        "ROEKO Cotton Pellets",
        "ROEKO Solomat-Click",
        "ROEKO Parotimat",
        "ROEKO Roll-o-mat",
        "REOKO Comprecap",
        "ROEKO Comprecap (anatomic)"
      ],
      "establishment_type": [
        "Manufacture Medical Device for Another Party (Contract Manufacturer)",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "8010629",
        "fei_number": "3001180585",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "COLTENE/WHALEDENT GMBH & CO. KG",
        "address_line_1": "RAIFFEISENSTRASSE 30",
        "address_line_2": "",
        "city": "LANGENAU Baden-Wurttemberg",
        "state_code": "",
        "iso_country_code": "DE",
        "zip_code": "",
        "postal_code": "89129",
        "us_agent": {
          "name": "Tricia Cregger",
          "business_name": "COLTENE/WHALEDENT INC.",
          "bus_phone_area_code": "330",
          "bus_phone_num": "9168904",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "Tricia.Cregger@coltene.com",
          "address_line_1": "235 Ascot Parkway",
          "address_line_2": "",
          "city": "Cuyahoga Falls",
          "state_code": "OH",
          "iso_country_code": "US",
          "zip_code": "44223",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "COLTENE Holding AG",
          "owner_operator_number": "9047609",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "FELDWIESENSTRASSE 20",
            "address_2": "--",
            "city": "ALTSTAETTEN",
            "state_code": "CH-SG",
            "state_province": "Sankt Gallen",
            "iso_country_code": "CH",
            "postal_code": "9450"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "EFN",
          "created_date": "1992-12-03",
          "owner_operator_number": "9047609",
          "exempt": "",
          "openfda": {
            "device_name": "Cotton, Roll",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.6050",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}