MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. NONTEMPLATE ALIGNER ARCH; ALIGNER, SEQUENTIAL

Catalog Number	00856379007023
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
In this event it is reported that patient experienced possible allergic reaction and an oral fungus on the tongue and irritations on buccal molar area near trim line.Doctor had patient stop aligner treatment and prescribed medication for the oral fungus, patient took medication for 1 week and it cleared up.Patient restarted aligners and the same condition came back worse.Patient could not eat or talk.Patient's parent to them to another dentist who confirmed it was a fungus and prescription prescribed was correct and to take again.Doctor spoke with patient's parent who advised that the prescription is not working, not getting any better.Patient will be taken to family physician.Further information requested, allergic reaction form and additional information requested and return of remaining aligners.
Additional Manufacturer Narrative
Dhr investigation: we reviewed the dhr for this (b)(6) / patient id# (b)(6) / site id# 24606, qty.(b)(4) items assy-500011 (aligners) and 2 items assy-500010 (templates) were packaged by the second shift by auto bag-and-box operation on june 24, 2025, in manufacturing supercell sc3, equipment pua-06.The sales order was inspected and met the acceptance criteria provided by qa.Incoming inspection.We reviewed the incoming inspection record for the material manufacturing of this so (b)(6).· raw material: part-501019 / lot# 265758 / qty.Received = (b)(4) rolls, inspection date: june 17, 2025.The material was found acceptable for use in the suresmile product's manufacture.Photo investigation: the evidence provided by the customer (photos) shows apparent redness on the inner lip and cheek area, as well as apparent lacerations on the patient¿s tongue.No evidence of the devices (aligners) is shown to allow for their evaluation; therefore, it is not possible to determine whether the patient¿s apparent injuries were caused by the devices.

• Brand Name: NONTEMPLATE ALIGNER ARCH
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer (Section G): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24108671
• Report Number: 1649995-2026-00001
• Device Sequence Number: 17596439
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00856379007023
• Device Lot Number: 10644434
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/16/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR
• Patient Sex: Female