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 Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
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 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 the nontemplate aligner arch aligners cutting the inside of the patient's upper lip.Further information requested.
Additional Manufacturer Narrative
Investigation results; dl protocol was followed.I do not see any digital defects with the models or the trim line that would cause this issue.I check every stage and the trimline looks good digitally.We reviewed the dhr for this (b)(6) / patient id# (b)(6) / site id# (b)(6), qty.(b)(4) items assy-500011 (aligners) and (b)(4) items assy-500010 (templates) were packaged by the second shift by auto bag-and-box operation on january 22, 2026, in manufacturing supercell sc4, equipment pua-04.The evidence provided by the customer (photos) shows a set of devices (apparently upper aligners for stages 1 and 2).We observe that the device identified as 1 has a scalloped trim line located over the trays of the central incisors, while the device identified as 2 has a trim line along the gingival edge of the dental trays.Comparative evaluation: we observe in the stl models that the scalloped trim line is specified along the gingival margin of the digital model.The evidence provided shows that the trim line of device 1 is out of specification according to the stl digital model.

• 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: 24267263
• Report Number: 1649995-2026-00003
• Device Sequence Number: 10031227
• 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): 04/28/2026

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: 02/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/28/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown