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FDANovember 4, 2024device

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 sys...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

straight smilestraight

UPCs

00850017524163

Recall history

No related federal recalls on record for this brand yet.

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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 sys... — Recall Details · AllClear