{
  "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": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "N",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "N",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "MW5005663",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20080222",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20080222",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        ""
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20080303",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20080222",
          "brand_name": "ESTHET X",
          "generic_name": "COMPOSITE",
          "manufacturer_d_name": "DENTSPLY INTERNATIONAL DENTSPLY CAULK",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "LAY USER/PATIENT",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "EBF",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Material, Tooth Shade, Resin",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.3690",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Other (for use when an appropriate device code cannot be identified)"
      ],
      "reporter_state_code": "MI",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250819",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
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          "date_received": "20080222",
          "sequence_number_treatment": [
            "DENTSPLY CAULK ESTHET X COMPOSITE"
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "34 YR",
          "patient_sex": "",
          "patient_weight": "54",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Unknown (for use when the patient's condition is not known)"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20080222",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1003386",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "800981",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "I TRIED TO CALL THE MANUFACTURER TO VERIFY INGREDIENTS BUT WAS TOLD BY BOTH THE MANUFACTURER AND CORPORATE HEADQUARTERS THAT AS A CONSUMER I AM NOT ENTILTED TO KNOW THE INGREDIENTS. I HAVE CELIAC SPRU ALONG WITH OTHER ALLERGIES. I AM TRYING TO GET MY TEETH FIXED BUT IN ORDER TO DO SO I HAVE TO VERIFY INGREDIENTS PRIOR TO ANY PRODUCT BEING PUT IN MY MOUTH. CONSUMERS HAVE EVERY RIGHT TO BE ABLE TO VERIFY WITH BUSINESSES WHAT INGREDIENTS THEY ARE USING IN ORDER TO PREVENT ADVERSE REACTIONS TO PRODUCTS. DIAGNOSIS OR REASON FOR USE DENTAL WORK."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}