MAUDE Adverse Event Report: ORTHO DENTAL LAB, LLC SMILESET; SMILESET NIGHTTIME ALIGNER

Model Number	122-0101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	12/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At the start of the third aligner the patient noticed she was unable to floss between her bottom left first molar and the second molar.Patient thought it would straighten out and the problem would resolve but about a week into the third aligner her filling came loose and her tooth cracked.
Additional Manufacturer Narrative
This mdr is being filed late due to a retrospective complaint review.No conclusive evidence has been provided that supports or opposes the fact that the smileset nighttime aligners caused or contributed to the patient's symptoms.This event is being filed as a mdr as the patient reported a loose filling and cracked tooth while a smileset nighttime aligner was being used.

• Brand Name: SMILESET
• Common Device Name: SMILESET NIGHTTIME ALIGNER
• 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: 25849913
• Report Number: 3032193293-2026-00004
• Device Sequence Number: 10614270
• Product Code: NXC
• UDI-Device Identifier: 00860014476105
• UDI-Public: (01)00860014476105(11)2025-10-17
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2026

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: 122-0101
• Device Lot Number: 213238
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• 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: 46 YR
• Patient Sex: Unknown