{
  "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": "2026-09-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 18
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Pac-Dent Barrier Sleeve, Cover It Barrier Film",
        "UNIVERSAL CURING LIGHT SHIELD",
        "Pinnacle Sleeves, Covers, Sheaths, Cover-All, Allrap Protective Barriers",
        "Air Techniques",
        "PSP Barrier Envelopes"
      ],
      "establishment_type": [
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      ],
      "registration": {
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        "fei_number": "3015491448",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "iBrite Suzhou Technology Co., Ltd",
        "address_line_1": "51 Zhousidun road",
        "address_line_2": "",
        "city": "SUZHOU CITY Jiangsu",
        "state_code": "",
        "iso_country_code": "CN",
        "zip_code": "",
        "postal_code": "215100",
        "us_agent": {
          "name": "Heather Hang",
          "business_name": "PAC-DENT, INC.",
          "bus_phone_area_code": "909",
          "bus_phone_num": "8390888",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "hang.m@pac-dent.com",
          "address_line_1": "670 Endeavor Cir",
          "address_line_2": "",
          "city": "Brea",
          "state_code": "CA",
          "iso_country_code": "US",
          "zip_code": "92821",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Pac-Dent Inc.",
          "owner_operator_number": "10056434",
          "official_correspondent": {
            "first_name": "Hang",
            "middle_initial": "",
            "last_name": "Luu",
            "subaccount_company_name": "",
            "phone_number": "1-909-8390888-115"
          },
          "contact_address": {
            "address_1": "670 Endeavor Cir",
            "address_2": "",
            "city": "Brea",
            "state_code": "CA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "92821"
          }
        }
      },
      "pma_number": "",
      "k_number": "K151123",
      "products": [
        {
          "product_code": "PEM",
          "created_date": "2017-12-21",
          "owner_operator_number": "10056434",
          "exempt": "",
          "openfda": {
            "k_number": [
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            "device_name": "Dental Barriers And Sleeves",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4370",
            "device_class": "2"
          }
        }
      ]
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}