{ "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": "2026-08-18", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "PA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "RICHARDSON", "manufacturer_contact_address_1": "221 WEST PHILADELPHIA ST.", "manufacturer_contact_pcity": "71784575", "event_type": "Injury", "report_number": "1649995-2024-00011", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20240507", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240425", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "17401", "reporter_occupation_code": "DENTIST", "manufacturer_contact_plocal": "7178457511", "noe_summarized": "1", "manufacturer_contact_l_name": "EAGAR", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "75082", "date_facility_aware": "20240426", "manufacturer_g1_state": "TX", "reporter_country_code": "US", "manufacturer_contact_area_code": "717", "date_added": "20240507", "manufacturer_contact_f_name": "DAN", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "454486", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240507", "brand_name": "ASPEN MOTTO NONTEMPLATE ALIGNER ARCH", "generic_name": "ALIGNER, SEQUENTIAL", "manufacturer_d_name": "DENTSPLY SIRONA ORTHODONTICS INC.", "manufacturer_d_address_1": "2350 CAMPBELL CREEK BLVD. SUIT", "manufacturer_d_address_2": "", "manufacturer_d_city": "RICHARDSON", "manufacturer_d_state": "TX", "manufacturer_d_zip_code": "75082", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "75082", "device_operator": "LAY USER/PATIENT", "model_number": "", "catalog_number": "ASSY-500018", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "NXC", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00856379007283", "udi_public": "00856379007283", "openfda": { "device_name": "Aligner, Sequential", "medical_specialty_description": "Dental", "regulation_number": "872.5470", "device_class": "2" } } ], "product_problems": [ "Patient-Device Incompatibility", "Patient-Device Incompatibility" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250820", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7178", "patient": [ { "patient_sequence_number": "1", "date_received": "20240507", "sequence_number_treatment": [ "NOT AVAILABLE" ], "sequence_number_outcome": [ "" ], "patient_age": "57 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hypersensitivity/Allergic reaction", "Hypersensitivity/Allergic reaction" ] } ], "distributor_city": "", "date_report": "20240726", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "YORK", "mdr_report_key": "19263799", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240426", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "75082", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "DENTSPLY SIRONA ORTHODONTICS INC.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "349434369", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION RESULTS: EVIDENCE: IN THE EVIDENCE PROVIDED BY THE CUSTOMER (ALLERGIC REACTION CHECKLIST), THE PATIENT DECLARES NOT TO SUFFER FROM ANY TYPE OF ALLERGY. IT ALSO DECLARES THAT IT HAS NOT TESTED THE PATIENT FOR AN ALLERGIC REACTION TO THE PRODUCT. DHR EVALUATION: WE REVIEWED THE DHR FOR THIS (B)(6) / PATIENT ID# (B)(6) / PRACTICE ID# (B)(6) QTY. (B)(4) ITEMS ASSY-500018 (ALIGNERS), AND (B)(4) ITEMS ASSY-500017 (TEMPLATE), WERE PACKAGED BY THE FIRST SHIFT BY BAG AND BOX OPERATION ON OCTOBER 10, 2023, MANUFACTURING CELL 3, EQUIPMENT BAG-5. THE SALES ORDER WAS INSPECTED AND MET WITH THE ACCEPTANCE CRITERIA PROVIDED BY QA. INCOMING INSPECTION. WE REVIEWED THE INCOMING INSPECTION RECORD FOR THE MATERIAL USED TO MANUFACTURE THIS (B)(6). · RAW MATERIAL: PART-70125-B / LOT# 07431012 / QTY. RECEIVED = (B)(4) PCS, INSPECTION DATE: AUGUST 25, 2023. · THE MATERIAL WAS FOUND TO BE ACCEPTABLE FOR USE IN THE MANUFACTURE OF THE SURE SMILE PRODUCT." }, { "mdr_text_key": "341984982", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "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. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE." }, { "mdr_text_key": "341984983", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IN THIS EVENT IT IS REPORTED THAT ASPEN MOTTO NONTEMPLATE ALIGNER ARCH THAT WAS USED BY A PATIENT FOR TREATMENT ALLEGEDLY THE PATIENT STARTED HAVING MINOR ALLERGIC REACTION TO THE ALIGNERS. SYMPTOMS INCLUDED AN ITCHY AND SORE THROAT, AS WELL AS THROAT SWELLING. REPORTEDLY, THIS STARTED WHEN THE PATIENT FIRST BEGAN TREATMENT AND WORSENING AROUND WEEK 26 OF ALIGNER THERAPY. AFTER DISCONTINUATION OF ALIGNER THERAPY, THE SYMPTOMS RESOLVED RIGHT AWAY. THE DENTAL PRACTICE USES VINYL, POWER FREE EXAM GLOVES IN THEIR OFFICE. THE PATIENT DID NOT SEEK ADDITIONAL MEDICAL TREATMENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "2350 CAMPBELL CREEK BLVD. SUIT", "distributor_zip_code": "", "manufacturer_contact_postal_code": "17401", "manufacturer_contact_exchange": "717", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/26/2024" } ] }