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	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a patient using the nontemplate aligner arch aligners experienced allergic reaction to the aligners.The patient experienced red and irritated gums with sores and blisters that developed on their lips.Multiple changes have been tried over the past few months that have not worked.The only relief the patient gets is when they do not have the aligners in their mouth.
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.
Additional Manufacturer Narrative
Investigation results dhr we reviewed the dhr for this so-sr05660719 / patient id# (b)(6) / site id# 07374, qty.58 items assy-500011 (aligners) and 2 items assy-500010 (templates) were packaged by the second shift by auto bag-and-box operation on october 16, 2025, in manufacturing supercell sc1, equipment pua-08.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-sr05660719.Raw material: part-501019 / lot# 265985 / qty.Received = 555 rolls, inspection date: august 12, 2025.The material was found acceptable for use in the suresmile product's manufacture.Photo investigation the evidence provided by the customer only shows the patient¿s allergic reaction checklist, in which the patient declares no known allergic reactions and also states that no testing was performed to assess allergies to the product.The patient reports symptoms such as irritated, sore gums and blisters on the lips; however, no supporting documentation is provided.Return we received the return of 52 aligners (stages 4¿29).The received aligners were in their packaging bags, completely sealed.We inspected the returned aligners (u4 sn: (b)(6) and l4 sn: (b)(6)) for patient id e8f8.No out-of-specification conditions were observed in the inspected aligners.The aligners meet the quality criteria specified in 0281-wi-aln-005-3, final quality control and aligner washing, visual detection of defects.

• 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: 24303810
• Report Number: 1649995-2026-00004
• Device Sequence Number: 5142778
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 11313991
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/07/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2025
• 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: 34 YR
• Patient Sex: Male