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)
Type of Reportable Event	Serious Injury
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 a patient experienced allergic reaction to the nontemplate aligner arch.Patient's symptoms included swollen lips, inside lips the area was very red, lips would burn while wearing the aligners.The doctor also mentioned that the patient is allergic to bonding agent and wants to see if the reaction caused by the aligners or bonding agent.Further information requested.
Additional Manufacturer Narrative
Investigation; we reviewed the dhr for this so-sr05694619 / patient id# (b)(6) / site id# 08803, qty.54 items assy-500011 (aligners) and 2 items assy-500010 (templates) were packaged by the second shift by auto bag-and-box operation on october 31, 2025, in manufacturing supercell sc2, equipment pua-03.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-sr05694619.· raw material: part-501019 / lot# 1-3-1-dsot0002 / qty.Received = 396 rolls, inspection date: (b)(6) 2025.The material was found acceptable for use in the suresmile product's manufacture.Photo investigation the evidence provided by the customer shows the patient¿s lips with apparent redness.No evidence of the devices (aligners) is shown to allow for their evaluation; therefore, it is not possible to determine whether the reddish discoloration of the patient¿s lips was caused by the aligners.

• 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: 24209086
• Report Number: 1649995-2026-00002
• Device Sequence Number: 21214253
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00856379007023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/28/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown