Byte Night Aligners NBYTETrayRecalls & reported problems
Straight Smile LLC · Sequential Aligners · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
These Byte Night clear dental aligners are removable trays used to straighten teeth. The reports often describe patients who say the aligners led to tooth fractures, gum cuts or irritation, loose teeth, and bite or jaw (TMJ) concerns. FDA records list 6,060 reports, no deaths, 5,309 injuries and 751 malfunctions. There is 1 open recall, which began in November 2024 and concerns a virtual-only approval process that may not suit patients with certain contraindications. Reports fell from 4,258 in the prior 12 months to 1,054 in the latest 12 months.
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
- 6,053
- Deaths reported
- 0
- Injuries reported
- 5,302
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6,053 adverse event reports that list this exact device (DI 00850017524170), received between Jul 19, 2024 and Sep 30, 2026 — classified as 5,302 injuries, 751 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (4,285 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. How this data works · Data updated Oct 13, 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 · FDA record ↗
Most reported problems
Device problems
- Patient-Device Incompatibility4,285
- Sharp Edges1,415
- Device Appears to Trigger Rejection802
- Defective Device667
- Inadequacy of Device Shape and/or Size294
- Lack of Effect182
- Unintended Movement174
- Structural Problem163
Patient problems
- Deformity/ Disfigurement3,127
- Tooth Fracture1,698
- Laceration(s)1,414
- Pain793
- Tooth Loss771
- Hypersensitivity/Allergic reaction748
- Necrosis725
- Swelling/ Edema683
Recent adverse event reports
The 25 most recent of 6,053 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50950821 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a Night Aligner Byte caused tooth resorption during treatment requiring a root canal.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50421460 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Night Aligner Byte caused gum recession.
Patient problems: Erosion
MAUDE report 50359598 ↗InjuryAug 19, 2026Unintended Movement
It was reported that the Night Aligner Byte caused misaligned bite.
Patient problems: Deformity/ Disfigurement
MAUDE report 50334152 ↗InjuryAug 19, 2026Structural Problem; Sharp Edges
It was reported that the Night Aligner Byte cut the patients gums.
Patient problems: Laceration(s)
MAUDE report 50334065 ↗InjuryAug 19, 2026Structural Problem; Adverse Event Without Identified Device or Use Problem
It was reported that the Night Aligner Byte caused pain and recession.
Patient problems: Erosion; Pain
MAUDE report 50334020 ↗InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem; Unintended Movement
Patient stated that they experienced tooth mobility, recession and tooth fracture due to Byte aligners.
Patient problems: Deformity/ Disfigurement; Erosion; Tooth Fracture
MAUDE report 50307387 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
Patient stated that they experienced tooth fracture due to Byte aligners.
Patient problems: Tooth Fracture
MAUDE report 50287642 ↗InjuryAug 12, 2026Patient-Device Incompatibility
Patient stated that they experienced gum irritation and cutting due to Byte aligners.
Patient problems: Deformity/ Disfigurement; Laceration(s)
MAUDE report 50218806 ↗InjuryJul 30, 2026Patient-Device Incompatibility
Patient stated that they experienced cuts to their gums due to Byte aligners.
Patient problems: Tissue Breakdown
MAUDE report 50092867 ↗InjuryJul 27, 2026Patient-Device Incompatibility
Patient stated that they experienced caries due to the Byte aligners.
Patient problems: Tissue Breakdown
MAUDE report 50048020 ↗InjuryJul 27, 2026Patient-Device Incompatibility
Patient stated that they experienced fractured tooth due to Byte aligner.
Patient problems: Tooth Fracture
MAUDE report 50008365 ↗InjuryJul 27, 2026Patient-Device Incompatibility
Patient stated that they experienced bite concerns and TMJ due to Byte aligners.
Patient problems: Deformity/ Disfigurement
MAUDE report 50008146 ↗InjuryJul 8, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED BITE CONCERNS DUE TO BYTE ALIGNER.
Patient problems: Deformity/ Disfigurement
MAUDE report 25748863 ↗InjuryJun 25, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED UNINTENDED MOVEMENT CAUSING AN OPEN BITE DUE TO BYTE ALIGNERS.
Patient problems: Deformity/ Disfigurement
MAUDE report 25619514 ↗InjuryJun 22, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED A FRACTURED TOOTH DUE TO BYTE ALIGNERS.
Patient problems: Tooth Fracture
MAUDE report 25579215 ↗InjuryJun 12, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED A FRACTURED TOOTH DUE TO BYTE ALIGNERS.
Patient problems: Tooth Fracture
MAUDE report 25486584 ↗InjuryJun 10, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED MOBILITY AND BITE CONCERNS DUE TO BYTE ALIGNERS.
Patient problems: Deformity/ Disfigurement; Tissue Breakdown
MAUDE report 25456786 ↗InjuryJun 4, 2026Patient-Device Incompatibility
THE PATIENT STATED THAT THEY EXPERIENCED A TOOTH FRACTURE DUE TO BYTE ALIGNERS.
Patient problems: Tooth Fracture
MAUDE report 25399887 ↗InjuryJun 4, 2026Patient-Device Incompatibility
THE PATIENT STATED THAT THEY EXPERIENCED MOBILITY AND TOOTH FRACTURE DUE TO THE BYTE ALIGNERS.
Patient problems: Tissue Breakdown; Tooth Fracture
MAUDE report 25399723 ↗InjuryMay 29, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED UNINTENDED BITE MOVEMENT DUE TO BYTE ALIGNERS.
Patient problems: Deformity/ Disfigurement
MAUDE report 25335675 ↗InjuryMay 26, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED TOOTH FRACTURE DUE TO BYTE ALIGNERS.
Patient problems: Tooth Fracture
MAUDE report 25279087 ↗InjuryMay 15, 2026Patient-Device Incompatibility
THE PATIENT STATED THAT THEY EXPERIENCE BITE ALIGNMENT WORSENED, SWELLING, AND TMJ DUE TO THE BYTE ALIGNER.
Patient problems: Deformity/ Disfigurement; Pain; Swelling/ Edema
MAUDE report 25194288 ↗InjuryMay 15, 2026Patient-Device Incompatibility
THE PATIENT STATED THAT THEY EXPERIENCED BITE MISALIGNMENT AND TMJ DUE TO THE BYTE ALIGNERS.
Patient problems: Deformity/ Disfigurement
MAUDE report 25194267 ↗InjuryMay 13, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED MOBILITY, FRACTURED TOOTH, MISALIGNED BITE, AND PAIN AND SENSITIVITY DUE TO BYTE ALIGNERS.
Patient problems: Deformity/ Disfigurement; Hypersensitivity/Allergic reaction; Tissue Breakdown; Tooth Fracture
MAUDE report 25160319 ↗
Other Aligner, Sequential devices
- Byte Day Alignes HBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,719 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™ 359-8363m Unitek Corporation · Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-8313m Unitek Corporation · Aligner, sequential1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.