{
  "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": 11
    }
  },
  "results": [
    {
      "proprietary_name": [
        "STATMATIC Spray",
        "STATCARE Handpiece Spray",
        "K-Spray Handpiece Spray"
      ],
      "establishment_type": [
        "Foreign Private Label Distributor",
        "Export Device to the United States But Perform No Other Operation on Device"
      ],
      "registration": {
        "registration_number": "8043629",
        "fei_number": "1000273801",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "SCICAN LTD.",
        "address_line_1": "1440 DON MILLS RD.",
        "address_line_2": "",
        "city": "TORONTO Ontario",
        "state_code": "",
        "iso_country_code": "CA",
        "zip_code": "",
        "postal_code": "M3B 3P9",
        "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/Whaledent AG",
          "owner_operator_number": "9089944",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "Altstaetten",
            "address_2": "Feldwiesenstrasse 20",
            "city": "Altstaetten",
            "state_code": "CH-SG",
            "state_province": "Sankt Gallen",
            "iso_country_code": "CH",
            "postal_code": "CH 9450"
          }
        }
      },
      "pma_number": "",
      "k_number": "K062418",
      "products": [
        {
          "product_code": "EFB",
          "created_date": "2018-12-13",
          "owner_operator_number": "9089944",
          "exempt": "",
          "openfda": {
            "device_name": "Handpiece, Air-Powered, Dental",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.4200",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}