inforMED
MalfunctionNXC

BYTE CLEAR ALIGNERS

Received Mar 17, 2026

Report MW5185276 · MDR key 24616869

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Product code (NXC)

Device

Generic name

Aligner, Sequential

Patient

NA · Female

  • Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

IN 2023 I PURCHASED A SET OF BYTE MAIL-ORDER CLEAR ALIGNERS FOR ORTHODONTIC TREATMENT. THE TREATMENT WAS MARKETED AS DENTIST-SUPERVISED AND SAFE TO COMPLETE REMOTELY. THERE WAS NO IMPROVEMENT IN MY TEETH ALIGNMENT AND I QUIT USING THEM AFTER THEY BEGAN MAKING MY TOP GUMS BLEED. AT THE TIME, I JUST SWALLOWED THE FINANCIAL LOSS AND FIGURED ALIGNERS WEREN'T A GOOD OPTION FOR ME. I ATTEMPTED TO RESOLVE THE MATTER DIRECTLY WITH BYTE BY REQUESTING A REFUND. I HAVE CONTACTED THE COMPANY MULTIPLE TIMES OVER SEVERAL MONTHS BUT HAVE ONLY RECEIVED AUTOMATED OR GENERIC RESPONSES AND NO MEANINGFUL RESOLUTION. THEY MADE ME SIGN A FIELD SAFETY NOTICE AFTER I ASKED FOR A REFUND, NOT PRIOR TO TREATMENT. AFTER LEARNING ABOUT REGULATORY SCRUTINY AND SAFETY CONCERNS RELATED TO BYTE'S MAIL-ORDER ORTHODONTIC PRACTICES, I BECAME CONCERNED THAT THE TREATMENT MAY NOT HAVE BEEN PROPERLY SUPERVISED AND IT WAS CLEAR THAT IT HAD BEEN FALSELY ADVERTISED. I AM SUBMITTING THIS REPORT SO THE ISSUE IS DOCUMENTED AS A POTENTIAL MEDICAL DEVICE CONCERN AND SO THAT THE TREATMENT EXPERIENCE IS REVIEWED. THERE HAS BEEN A TON OF REGULATORY SCRUTINY SURROUNDING THE LEGITIMACY AND SAFETY OF BYTE ALIGNERS. THEY HAD TO SUSPEND SELLING THEM BECAUSE OF IT. I SPENT $1,999.00 ON THESE. THAT WAS A SIGNIFICANT FINANCIAL LOSS FOR ME.