Motto ASSY-500118Recalls & reported problems
Orametrix, Inc. · Motto Aligner · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00856379007283), received between May 7, 2024 and Jun 20, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility1
- Sharp Edges1
Patient problems
- Hypersensitivity/Allergic reaction1
- Laceration(s)1
- Tissue Breakdown1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2024Sharp Edges; Sharp Edges
IN THIS EVENT IT IS REPORTED THAT ASPEN MOTTO NONTEMPLATE ALIGNER ARCH HAS SHARP EDGES. THE SHARP EDGES ON THE ALIGNERS WHERE FILED DOWN BUT THE PATIENT EXPERIENCED THE SHARP EDGES CUTTING INTO THEIR GUMS.
Patient problems: Laceration(s); Tissue Breakdown
MAUDE report 19573591 ↗InjuryMay 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT ASPEN MOTTO NONTEMPLATE ALIGNER ARCH THAT WAS USED BY A PATIENT FOR TREATMENT ALLEGEDLY THE PATIENT STARTED HAVING MINOR ALLERGIC REACTION TO THE ALIGNERS. SYMPTOMS INCLUDED AN ITCHY AND SORE THROAT, AS WELL AS THROAT SWELLING. REPORTEDLY, THIS STARTED WHEN THE PATIENT FIRST BEGAN TREATMENT AND WORSENING AROUND WEEK 26 OF ALIGNER THERAPY. AFTER DISCONTINUATION OF ALIGNER THERAPY, THE SYMPTOMS RESOLVED RIGHT AWAY. THE DENTAL PRACTICE USES VINYL, POWER FREE EXAM GLOVES IN THEIR OFFICE. THE PATIENT DID NOT SEEK ADDITIONAL MEDICAL TREATMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19263799 ↗
Other Aligner, sequential devices
- Byte Day Alignes HBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,719 reports
- Byte Night Aligners NBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,053 reports
- sequential aligner 100-0352Access Dental Lab, LLC · Aligner, Sequential322 reports
- Invisalign System - Comprehensive 9000Align Technology, Inc. · Aligner, Sequential239 reports
- SureSmile® 1000Orametrix, Inc. · Aligner, Sequential134 reports
- REFINEMENT CORRECTION KIT 100-0012Access Dental Lab, LLC · Aligner, Sequential120 reports
- Candid Aligner FA-0001Candid Care CO. · Aligner, Sequential54 reports
- 3M™ Clarity™ 359-8353m Unitek Corporation · Aligner, sequential1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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