MAUDE Adverse Event Report: Dentsply Sirona Orthodontics Inc. NONTEMPLATE ALIGNER ARCH; Aligner, Sequential

Catalog Number	00856379007023
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Laceration(s) (1946); Discomfort (2330)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• 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 ; +1(717)845-7511
• MDR Report Key: 50082813
• Report Number: 1649995-2026-00048
• Device Sequence Number: 18696937
• 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: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2026

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: 12418277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2026
• 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
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male