MAUDE Adverse Event Report: ORTHO DENTAL LAB, LLC SmileSet; SmileSet All-Day Aligners

Model Number	121-0101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient noted crown on tooth #31 (lower right) lifting.
Additional Manufacturer Narrative
No conclusive evidence has been provided that supports or opposes the fact that the smileset all-day aligners caused or contributed to the patient's symptoms.This event is being filed as a mdr as it was alleged the patient's crown loosened while smileset all-day aligners were being used.

• Brand Name: SmileSet
• Common Device Name: SmileSet All-Day Aligners
• Manufacturer (Section D): ORTHO DENTAL LAB, LLC; 1530 antioch pike; antioch TN 37013
• Manufacturer (Section G): ORTHO DENTAL LAB, LLC; 1530 antioch pike; antioch TN 37013
• Manufacturer Contact: josh kessler ; 1530 antioch pike; antioch, TN 37013
• MDR Report Key: 50243892
• Report Number: 3032193293-2026-00007
• Device Sequence Number: 21424234
• Product Code: NXC
• UDI-Device Identifier: 00860012825509
• UDI-Public: (01)00860012825509(11)2026-03-16
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K212496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: Lay User/Patient
• Device Model Number: 121-0101
• Device Catalogue Number: 121-0101
• Device Lot Number: 304592
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Unknown