{
  "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": 12
    }
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  "results": [
    {
      "proprietary_name": [
        "Irrigation needles"
      ],
      "establishment_type": [
        "Manufacture Medical Device",
        "Export Device to the United States But Perform No Other Operation on Device"
      ],
      "registration": {
        "registration_number": "3015526995",
        "fei_number": "3015526995",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "UNITED DENTAL CHANGZHOU",
        "address_line_1": "B1, C1, D2, F2, No. 9 Changyang Road, West Taihu Science and Technology Industrial Park",
        "address_line_2": "",
        "city": "Changzhou Jiangsu",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "213145",
        "us_agent": {
          "name": "Leeyeo Kee",
          "business_name": "Regrek LLC",
          "bus_phone_area_code": "302",
          "bus_phone_num": "6089028",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "regrek.cs@hotmail.com",
          "address_line_1": "19 Holly Cove Ln.,",
          "address_line_2": "",
          "city": "Dover",
          "state_code": "DE",
          "iso_country_code": "US",
          "zip_code": "19901",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "United Dental Changzhou",
          "owner_operator_number": "10062136",
          "official_correspondent": {
            "first_name": "Yue",
            "middle_initial": "",
            "last_name": "Wu",
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            "phone_number": "86-135-84516342-x"
          },
          "contact_address": {
            "address_1": "B1, C1, D2, F2, No. 9 Changyang Road, West Taihu Science and Technology Industrial Park",
            "address_2": "",
            "city": "Changzhou",
            "state_code": "CN-JS",
            "state_province": "Jiangsu",
            "iso_country_code": "CN",
            "postal_code": "213145"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "EFS",
          "created_date": "2019-12-23",
          "owner_operator_number": "10062136",
          "exempt": "",
          "openfda": {
            "device_name": "Unit, Oral Irrigation",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.6510",
            "device_class": "1"
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        }
      ]
    }
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}