Byte Retainer BYTERetainerTrayRecalls & reported problems
Straight Smile LLC · Dental retainer · Class 1
Quick summary
This Straight Smile Byte retainer is a preformed dental positioner that holds teeth in place. Many reports describe patients with tooth fractures, cuts, jaw joint pain and bite changes. The records include 1,953 reports, 1,674 injuries and no deaths, and no recalls name this device.
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
- 1,954
- Deaths reported
- 0
- Injuries reported
- 1,675
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,954 adverse event reports that list this exact device (DI 00850017524187), received between Jul 23, 2024 and Aug 20, 2026 — classified as 1,675 injuries, 279 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1,026 reports).
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
Most reported problems
Device problems
- Patient-Device Incompatibility1,026
- Sharp Edges851
- Device Appears to Trigger Rejection614
- Defective Device574
- Unintended Movement50
- Inadequacy of Device Shape and/or Size38
- Structural Problem30
- Lack of Effect21
Patient problems
- Deformity/ Disfigurement1,062
- Tooth Fracture870
- Laceration(s)843
- Hypersensitivity/Allergic reaction615
- Tooth Loss594
- Necrosis582
- Swelling/ Edema577
- Abscess575
Recent adverse event reports
The 25 most recent of 1,954 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem; Unintended Movement
It was reported that the Day Retainer Byte caused mobility and bite alignment issues.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50358913 ↗InjuryJul 27, 2026Patient-Device Incompatibility
Patient stated that they experienced a broken tooth and bite concerns due to Byte retainer.
Patient problems: Deformity/ Disfigurement; Tooth Fracture
MAUDE report 50017628 ↗InjuryJun 29, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED TMJ AND GUM DAMAGE DUE TO BYTE RETAINER.
Patient problems: Deformity/ Disfigurement; Tissue Breakdown
MAUDE report 25653307 ↗InjuryJun 12, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED BITE CONCERNS AND SORES DUE TO BYTE RETAINER.
Patient problems: Abrasion; Deformity/ Disfigurement; Laceration(s)
MAUDE report 25485990 ↗InjuryMay 29, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED FRACTURED TOOTH DUE TO BYTE RETAINER.
Patient problems: Tooth Fracture
MAUDE report 25337476 ↗InjuryMay 26, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED TOOTH MOBILITY, PERIODONTAL DISEASE, POSTERIOR OPEN BITE, BONE LOSS, ROOT RESORPTION, AND WORSENING CROWDING DUE TO BYTE RETAINERS.
Patient problems: Deformity/ Disfigurement; Tissue Breakdown
MAUDE report 25277869 ↗InjuryMay 7, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED TMJ SYMPTOMS DUE TO BYTE RETAINER.
Patient problems: Deformity/ Disfigurement
MAUDE report 25112524 ↗InjuryMay 4, 2026Patient-Device Incompatibility
PATIENT STATED THAT THEY EXPERIENCED UNINTENDED MOVEMENT, DIFFICULTY WITH CHEWING, AND TEETH DAMAGE WHILE USING BYTE RETAINER.
Patient problems: Deformity/ Disfigurement
MAUDE report 25071344 ↗InjuryMay 1, 2026Unintended Movement
CUSTOMER STATED THEIR BITE WAS STILL MISALIGNED, THEY HAD PAIN AND TEETH GRINDING.
Patient problems: Pain
MAUDE report 25060330 ↗InjuryApr 29, 2026Unintended Movement
CUSTOMER STATED THEIR UNDERBITE WORSENED DUE TO THE RETAINERS.
Patient problems: Unspecified Musculoskeletal problem
MAUDE report 25029873 ↗InjuryApr 27, 2026Patient-Device Incompatibility
CUSTOMER STATED THEY HAD TOOTH DAMAGE DUE TO THE RETAINERS.
Patient problems: Deformity/ Disfigurement
MAUDE report 25010635 ↗InjuryApr 24, 2026Unintended Movement
CUSTOMER STATED THEY DEVELOPED A LOOSE TOOTH SIGNIFICANT PAIN AND MISALIGNMENT DUE TO THE RETAINERS.
Patient problems: Deformity/ Disfigurement; Pain
MAUDE report 24990627 ↗InjuryApr 15, 2026Patient-Device Incompatibility
CUSTOMER STATED THEY HAD TOOTH SENSITIVITY, AND PERIODONTAL DISEASE DUE TO THE RETAINERS.
Patient problems: Bacterial Infection; Sensitivity of Teeth
MAUDE report 24880746 ↗InjuryApr 15, 2026Unintended Movement
CUSTOMER STATED THE RETAINERS ARE MOVING THEIR TEETH SLANTED TO THE RIGHT CAUSING SOME TOOTH PAIN. CONTRAINDICDATED.
Patient problems: Pain
MAUDE report 24880710 ↗InjuryApr 13, 2026Patient-Device Incompatibility
CUSTOMER STATED THEY HAD DISCOMFORT, TEETH SENSITIVITY AND JAW PAIN DUE TO THE RETAINERS.
Patient problems: Discomfort; Pain; Sensitivity of Teeth
MAUDE report 24867959 ↗InjuryApr 13, 2026Patient-Device Incompatibility
CUSTOMER STATED THEIR TEETH ARE CRACKING DUE TO THE RETAINERS. CONTRAINDICATED.
Patient problems: Tooth Fracture
MAUDE report 24867929 ↗InjuryApr 8, 2026Device Appears to Trigger Rejection; Defective Device; Sharp Edges
IT WAS ALLEGED THAT BYTE¿S PRODUCTS HAVE CAUSED A BROAD RANGE OF COMPLICATIONS, INCLUDING BUT NOT LIMITED TO, ALLERGIC REACTIONS, BITE MISALIGNMENT, BONE LOSS, BREAKING AND CHIPPING OF TEETH, CUTTING OF GUMS DUE TO ALIGNERS¿ SHARP EDGES, FACIAL SWELLING AND ABSCESS IN MOUTH, GUM RECESSION, NECROSIS, TOOTH FRACTURES, AND WORSENING OF PATIENT BITE.
Patient problems: Abscess; Deformity/ Disfigurement; Hypersensitivity/Allergic reaction; Laceration(s); Necrosis; Swelling/ Edema; Tooth Fracture; Tooth Loss
MAUDE report 24815583 ↗InjuryApr 7, 2026Device Appears to Trigger Rejection; Defective Device; Sharp Edges
IT WAS ALLEGED THAT BYTE¿S PRODUCTS HAVE CAUSED A BROAD RANGE OF COMPLICATIONS, INCLUDING BUT NOT LIMITED TO, ALLERGIC REACTIONS, BITE MISALIGNMENT, BONE LOSS, BREAKING AND CHIPPING OF TEETH, CUTTING OF GUMS DUE TO ALIGNERS¿ SHARP EDGES, FACIAL SWELLING AND ABSCESS IN MOUTH, GUM RECESSION, NECROSIS, TOOTH FRACTURES, AND WORSENING OF PATIENT BITE.
Patient problems: Abscess; Deformity/ Disfigurement; Hypersensitivity/Allergic reaction; Laceration(s); Necrosis; Swelling/ Edema; Tooth Fracture; Tooth Loss
MAUDE report 24800247 ↗InjuryApr 2, 2026Unintended Movement
CUSTOMER STATED THEY CHIPPED THEIR TOOTH DUE TO THE RETAINERS AND EXPERIENCED IMPROPER TOOTH MOVEMENT.
Patient problems: Tooth Fracture
MAUDE report 24772768 ↗InjuryMar 30, 2026Patient-Device Incompatibility
CUSTOMER STATED THEY HAD A CHIPPED TOOTH DUE TO THE RETAINERS.
Patient problems: Tooth Fracture
MAUDE report 24737880 ↗InjuryMar 30, 2026Patient-Device Incompatibility
CUSTOMER STATED THEY HAVE TEETH INFLAMMATION AND SENSITIVITY DUE TO THE RETAINERS.
Patient problems: Sensitivity of Teeth; Stomatitis
MAUDE report 24737812 ↗InjuryMar 30, 2026Patient-Device Incompatibility
CUSTOMER STATED THEY HAD PAIN, TEETH SENSITIVITY AND CHIPPED A TOOTH DUE TO THE RETAINERS.
Patient problems: Pain; Sensitivity of Teeth; Tooth Fracture
MAUDE report 24737736 ↗InjuryMar 30, 2026Patient-Device Incompatibility
CUSTOMER STATED THEY HAD TEETH SENSITIVITY DUE TO THE RETAINERS.
Patient problems: Sensitivity of Teeth
MAUDE report 24737424 ↗InjuryMar 30, 2026Patient-Device Incompatibility
CUSTOMER STATED THEY CHIPPED THEIR FRONT TOOTH DUE TO THE RETAINERS. CONTRAINDICATED.
Patient problems: Tooth Fracture
MAUDE report 24722349 ↗InjuryMar 30, 2026Unintended Movement
CUSTOMER STATED THEY HAVE AN OVERBITE DUE TO THE RETAINERS.
Patient problems: Unspecified Musculoskeletal problem
MAUDE report 24721971 ↗
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- SureSmile® 1000Orametrix, Inc. · Positioner, Tooth, Preformed39 reports
- SmileSet Retainers 140-0101Ortho Dental Lab LLC · Positioner, Tooth, Preformed17 reports
- ClearCorrect System RetainerClearcorrect Operating, LLC · Positioner, Tooth, Preformed3 reports
- IPS 60-500-01-09KLS-Martin L.P. · POSITIONER, TOOTH, PREFORMED2 reports
- Essix A+ 10045Dentsply Sirona Orthodontics Inc. · POSITIONER, TOOTH, PREFORMED1 report
- Herbst Bite Jumper 3000-0010Allesee Aoa-Pro · POSITIONER, TOOTH, PREFORMED1 report
- Distal Jet 3000-0090Allesee Aoa-Pro · POSITIONER, TOOTH, PREFORMED1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.