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); Tissue Breakdown (2681)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Event or Problem Description
In this event it is reported that non template aligner arch - suresmile aligners - have sharp edges that are injuring and cutting the patient's tongue.The doctor is requesting the edges to be polished, or that these areas be adjusted so that they merely graze the gum tissue, thereby preventing injury to the tongue.

• 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: 25173828
• Report Number: 1649995-2026-00018
• Device Sequence Number: 16000036
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 07/08/2026
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown