{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "122152",
      "product_res_number": "Z-0376-2014",
      "event_date_initiated": "2013-09-23",
      "event_date_posted": "2013-11-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-05-27",
      "res_event_number": "66359",
      "product_code": "MZW",
      "k_numbers": [
        "K093744"
      ],
      "product_description": "ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50\n\n dental adhesive for restorations",
      "code_info": "Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015",
      "firm_fei_number": "1316092",
      "recalling_firm": "Ivoclar Vivadent, Inc.",
      "address_1": "175 Pineview Dr",
      "city": "Buffalo",
      "state": "NY",
      "postal_code": "14228-2231",
      "additional_info_contact": "716-691-0010",
      "reason_for_recall": "Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.",
      "root_cause_description": "Material/Component Contamination",
      "action": "The firm, Ivoclar Vivadent, Inc., sent an \"URGENT MEDICAL DEVICE RECALL\" letter dated September 19, 2013 via first class mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check your stock and segregate any material marked batch R59595; contact the Ivoclar Vivadent Customer Service at 800-533-6825 as soon as possible between the hours of 9:00am and 7:00pm EST Monday through Friday and a representative will arrange to have your stock replaced; both unopened and opened packages can be returned; and complete and return the Medical Device Recall Return Response Acknowledgment and Receipt Form.\n\nPlease communicate locally with Ivoclar Vivadent Customer Service at 800-533-6825 for any questions.",
      "product_quantity": "63 refill packs (50 single use applications per refill)",
      "distribution_pattern": "US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.",
      "openfda": {
        "k_number": [
          "K073209",
          "K991923"
        ],
        "device_name": "Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.3275",
        "device_class": "2",
        "registration_number": [
          "3008912871",
          "3012421607",
          "3032378317",
          "3012187973",
          "2024312",
          "3044819802",
          "9680845",
          "3045857207",
          "8020994",
          "3006316962",
          "3038718579"
        ],
        "fei_number": [
          "3008912871",
          "3012421607",
          "3032378317",
          "3012187973",
          "3000368601",
          "2024312",
          "3044819802",
          "3045857207",
          "3006316962",
          "1000231788",
          "3038718579"
        ]
      }
    }
  ]
}