MAUDE Adverse Event Report: Dentsply Sirona Orthodontics Inc. - Richardson SURESMILE ALIGNER ARCH; aligner, sequential

Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a possible allergic reaction.

• Brand Name: SURESMILE ALIGNER ARCH
• Common Device Name: aligner, sequential
• Manufacturer (Section D): Dentsply Sirona Orthodontics Inc. - Richardson; 2350 campbell creek blvd. suit; richardson
• Manufacturer Contact: mr. dan eagar; suite 60w; york, PA 17401
• MDR Report Key: 50936731
• Report Number: 1649995-2026-00553
• Device Sequence Number: 9598090
• Product Code: NXC
• UDI-Device Identifier: 00856379007313
• UDI-Public: 00856379007313
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Unknown