Byte Day Alignes HBYTETrayRecalls & reported problems
Straight Smile LLC · Sequential Aligners · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Byte Day clear aligner is a plastic tray used to move teeth. Of its 6,726 reports, none are deaths and 5,262 are injuries. Many describe poor fit, sharp edges, fractured teeth, bite problems or jaw discomfort. There is 1 open recall from November 2024 saying the virtual-only approval process may not suit some patients with certain conditions. Reports fell from 4,460 in the prior year to 1,268 in the latest year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 6,719
- Deaths reported
- 0
- Injuries reported
- 5,255
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6,719 adverse event reports that list this exact device (DI 00850017524163), received between Jul 22, 2024 and Sep 30, 2026 — classified as 5,255 injuries, 1,464 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (3,914 reports).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Reports received per month
Recalls naming this device
- Nov 4, 2024Open, Classified
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.
Z-0750-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Patient-Device Incompatibility3,914
- Sharp Edges2,564
- Device Appears to Trigger Rejection1,131
- Defective Device978
- Inadequacy of Device Shape and/or Size273
- Structural Problem185
- Unintended Movement144
- Lack of Effect142
Patient problems
- Deformity/ Disfigurement3,122
- Laceration(s)2,532
- Tooth Fracture1,829
- Hypersensitivity/Allergic reaction1,118
- Tooth Loss1,060
- Necrosis1,059
- Swelling/ Edema1,009
- Abscess982
Recent adverse event reports
The 25 most recent of 6,719 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Structural Problem; Adverse Event Without Identified Device or Use Problem; Sharp Edges
It was reported that Day Aligner Byte caused the patient worsening bite, gum recession, tooth discoloration, periodontal issues, and cutting due to sharp edge.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50945466 ↗MalfunctionAug 27, 2026Adverse Event Without Identified Device or Use Problem; Unintended Movement
It was reported that Day Aligner Byte caused the patient an anterior open bite, masticatory muscle fatigue, and TMJ discomfort.
Patient problems: Deformity/ Disfigurement; Non-malignant Neoplasm; Pain
MAUDE report 50473260 ↗InjuryAug 19, 2026Structural Problem; Adverse Event Without Identified Device or Use Problem
It was reported that the Night Aligner Byte cut the patients gums.
Patient problems: Erosion; Pain
MAUDE report 50333409 ↗InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem; Unintended Movement
Patient stated that they experienced tooth fracture due to Byte aligners.
Patient problems: Tooth Fracture
MAUDE report 50300100 ↗InjuryAug 17, 2026Structural Problem; Adverse Event Without Identified Device or Use Problem
Patient stated that they experienced fractured tooth due to Byte aligners.
Patient problems: Tooth Fracture
MAUDE report 50286744 ↗InjuryAug 11, 2026Patient-Device Incompatibility
Patient stated that they experienced a fractured tooth due to Byte aligners.
Patient problems: Tooth Fracture
MAUDE report 50209608 ↗InjuryAug 11, 2026Patient-Device Incompatibility
Patient stated that they experienced unintended movement and bite concerns due to Byte aligners.
Patient problems: Deformity/ Disfigurement
MAUDE report 50209252 ↗InjuryJul 31, 2026Patient-Device Incompatibility
Patient stated that they experienced bite concerns and broken tooth due to Byte aligners.
Patient problems: Deformity/ Disfigurement; Tooth Fracture
MAUDE report 50107480 ↗InjuryJul 30, 2026Patient-Device Incompatibility
Patient stated that they experienced bite concerns due to Byte aligners.
Patient problems: Deformity/ Disfigurement
MAUDE report 50093279 ↗InjuryJul 27, 2026Patient-Device Incompatibility
Patient stated that they experienced sensitivity of teeth and discoloration due to Byte aligners.
Patient problems: Sensitivity of Teeth
MAUDE report 50047991 ↗InjuryJul 27, 2026Patient-Device Incompatibility
Patient stated that they experienced a fractured tooth, bite concerns and TMJ due to Byte aligners.
Patient problems: Deformity/ Disfigurement; Tooth Fracture
MAUDE report 50047899 ↗InjuryJul 27, 2026Patient-Device Incompatibility
Patient stated that they experienced recession due to Byte aligners.
Patient problems: Tissue Breakdown
MAUDE report 50007911 ↗InjuryJul 27, 2026Patient-Device Incompatibility
Patient stated that they experienced fractured tooth and bite concerns due to Byte aligner.
Patient problems: Deformity/ Disfigurement; Tooth Fracture
MAUDE report 50007605 ↗InjuryJul 14, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED INFLAMMATION AND RECESSION DUE TO BYTE ALIGNERS.
Patient problems: Tissue Breakdown
MAUDE report 25811401 ↗InjuryJul 14, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED TMJ, BITE CONCERNS, AND FRACTURED TOOTH DUE TO BYTE ALIGNERS.
Patient problems: Deformity/ Disfigurement; Tooth Fracture
MAUDE report 25811340 ↗InjuryJul 8, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED WORSENING OF BITE, TMJ, AND RECESSION DUE TO BYTE ALIGNER.
Patient problems: Deformity/ Disfigurement; Tissue Breakdown
MAUDE report 25748520 ↗InjuryJul 8, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED A FRACTURED TOOTH DUE TO BYTE ALIGNER.
Patient problems: Tooth Fracture
MAUDE report 25747950 ↗InjuryJun 19, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED TOOTH LOSS DUE TO BYTE ALIGNERS.
Patient problems: Tooth Loss
MAUDE report 25564065 ↗InjuryJun 15, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED TMJ DUE TO BYTE ALIGNERS.
Patient problems: Deformity/ Disfigurement
MAUDE report 25501294 ↗InjuryJun 10, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED BITE CONCERNS AND MOBILITY DUE TO BYTE ALIGNERS.
Patient problems: Deformity/ Disfigurement; Tissue Breakdown
MAUDE report 25456697 ↗InjuryMay 27, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED GUM DAMAGE AND A BROKEN FIXED RESTORATION DUE TO BYTE ALIGNERS.
Patient problems: Tissue Breakdown; Tooth Fracture
MAUDE report 25305925 ↗InjuryMay 27, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED A FRACTURED TOOTH DUE TO BYTE ALIGNERS.
Patient problems: Tooth Fracture
MAUDE report 25305847 ↗InjuryMay 26, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED BITE MISALIGNMENT AND A BROKEN FIXED RESTORATION DUE TO THE BYTE ALIGNERS.
Patient problems: Deformity/ Disfigurement
MAUDE report 25279051 ↗InjuryMay 26, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED TOOTH FRACTURE DUE TO BYTE ALIGNERS.
Patient problems: Tooth Fracture
MAUDE report 25277338 ↗InjuryMay 12, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED WORSENED TMJ DUE TO BYTE ALIGNERS.
Patient problems: Tissue Breakdown
MAUDE report 25147920 ↗
Other Aligner, Sequential devices
- 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™ 359-8343m Unitek Corporation · Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-8323m 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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