HyperByte ASM-20018-05Recalls & reported problems

Propel Orthodontics LLC · HyperByte is an orthodontic accessory device intended for use during orthodontic treatment to facilitate minor anterior tooth movement. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00852673007127), received between Feb 11, 2021 and Feb 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Emits Odor” (1 report).

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.

Most reported problems

Device problems

Device Emits Odor1
Melted1
Overheating of Device1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 11, 2021Melted; Device Emits Odor; Overheating of Device
I RECENTLY BEGAN USING THE BYTE ALIGNERS FOR MY TEETH. PART OF THE TREATMENT INCLUDES THEIR PROPRIETARY AND 'FDA CLEARED' HYBERBYTE DEVICE. IT COMES WITH MICRO A USB CHARGING PORT AND CABLE TO CHARGE AND POWER IT. THE DEVICE INDICATOR LIGHT ALERTED ME THAT IT NEEDED TO BE CHARGED YESTERDAY, SO I PLUGGED IT INTO A DEDICATED USB CHARGING PORT ON ONE OF MY USB HUBS, AND A COUPLE OF HOURS LATER, WHEN I RETURNED FOR IT, I NOTICED A BURNING ELECTRICAL SMELL. I WASN'T SURE WHERE IT WAS COMING FROM UNTIL I PICKED UP THE HYBERBYTE, WHICH I IMMEDIATELY DROPPED, BECAUSE IT WAS BURNING HOT. TOO HOT TO HOLD. I THEN SAW IT HAD BROWN SCORCH MARKS AROUND WHERE THE MICRO USB CABLE SEATS INTO THE DEVICE, THERE WAS MELTED AND BUBBLING PLASTIC, AND THE CABLE END WAS BURNED AND CRACKED. I IMMEDIATELY PULLED THE USB CABLE LOOSE FROM THE OTHER END, WHERE IT WAS ATTACHED TO MY HUB. (THE HUB WAS AND IS FINE, STILL SUPPORTING OTHER CONNECTED DEVICES, AND THE HUB END OF THE CONNECTING CABLE WAS PERFECTLY COOL - THE HEAT WAS COMING FROM THE HYBERBYTE, SO I CAN ONLY ASSUME WHATEVER WAS SHORTING IS IN THERE) THE BURNED END OF THE CABLE NOW APPEARS TO BE PERMANENTLY FUSED TO THE MICRO USB PORT IN/ON THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11321559 ↗

Device details

UDI-DI	`00852673007127`
Brand	HyperByte
Model	ASM-20018-05
Company	Propel Orthodontics LLC
Product code	OYH · Orthodontic Vibratory Accessory
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 9, 2022

Device type (GMDN): Orthodontic vibrator

An electronic device designed to be used in the home during treatment with orthodontic appliances (e.g., brackets, aligners) to provide small vibrations for gently accelerating the movement of anterior teeth, guided by the appliances, to help reduce treatment time and pain. It is in the form of a biteable plastic mouthpiece attached to a hands-free vibratory unit. This is a reusable device.

Other Orthodontic Vibratory Accessory devices

Byte V18115
Dentsply International Inc. · Orthodontic vibratory accessory
3 reports

All Orthodontic Vibratory Accessory devices →

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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