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.
Event or Problem Description
In this event it is reported that a patient experienced an allergic reaction to the nontemplate aligner arch aligners.The doctor states the patient's tongue was scaling and rough.Once the patient stopped wearing the aligners there was improvement.Patient was advised to stop treatment immediately.
Additional Manufacturer Narrative
Dhr we reviewed the dhr for this (b)(4) / patient id# (b)(6) / site id# (b)(6), qty.(b)(4) items assy-500011 (aligners) and 2 items assy-500010 (templates) were packaged by the second shift by bag-and-box operation on (b)(6) 2025, in manufacturing supercell sc0, equipment bag-15.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 (b)(4).· raw material: part-501019 / lot# 265985 / qty.Received = (b)(4) rolls, inspection date: (b)(6) 2025.The material was found acceptable for use in the suresmile product's manufacture.Failure mode - allergic reaction.Root cause - no defect.Conclusion code - no failure found.

• 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: 23788531
• Report Number: 1649995-2025-00076
• Device Sequence Number: 5522027
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/27/2026

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
• Device Catalogue Number: 00856379007023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/08/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown