Straight Smile LLC
FDA adverse event reports naming Straight Smile LLC as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: STRAIGHT SMILE LLC.
- Total reports
- 4,907
- Deaths
- 0
- Injuries
- 4,847
- Malfunctions
- 60
Reports per year
Source: FDA adverse event reports by year received, 2024–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2024-12-23Open, ClassifiedDevice Design
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.
Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
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