{ "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, "total": 51 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "9681199-2008-00006", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080222", "manufacturer_address_2": "", "pma_pmn_number": "K022796", "date_of_event": "20080124", "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": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20080226", "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": "CERCON CERAM KISS GLAZE", "generic_name": "", "manufacturer_d_name": "DENTSPLY PROSTHETICS", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "YORK", "manufacturer_d_state": "PA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "NA", "catalog_number": "67163503", "lot_number": "UNK", "other_id_number": "NA", "device_availability": "No", "device_report_product_code": "EIH", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "9681199" ], "fei_number": [ "3003999430" ], "device_name": "Powder, Porcelain", "medical_specialty_description": "Dental", "regulation_number": "872.6660", "device_class": "2" } } ], "product_problems": [ "Unknown (for use when the device problem is not known)" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250729", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20080222", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "UNK YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Allergic reaction", "Itching Sensation", "Swelling", "Therapy/non-surgical treatment, additional" ] } ], "distributor_city": "", "date_report": "20080125", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1001071", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080125", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "19327194", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. FURTHER INFORMATION PERTAINING TO OUTCOME OF THIS EVENT WILL BE REPORTED IF IT BECOMES AVAILABLE." }, { "mdr_text_key": "19176373", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT A PATIENT DEVELOPED SWELLING OF THE LIPS AND GUMS WITH AN ITCHING SENSATION AFTER USE OF A PROSTHETIC FASHIONED USING CERCON CERAM KISS GLAZE. THE PATIENT SOUGHT TREATMENT FROM AN ALLERGY SPECIALIST AND WAS DETERMINED TO BE ALLERGIC TO COBALT, CHROMIUM, AND COBALT DICHLORIDE (NONE OF WHICH ARE COMPONENTS OF THE KISS GLAZE); THE EXACT TREATMENT ADMINISTERED, IF ANY, IS UNKNOWN AS OF THIS REPORT." } ], "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": "" } ] }