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Byte and Dentsply Sirona Sued Over Alleged Dangerous At-Home Aligners

Published:

June 18, 2025
  • Corporate Lawsuits
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Byte Face Dental Aligner Class Action Lawsuit

Patients say Byte dental products cause tooth loss and gum damage.

Last Updated:

06/18/2025

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In a troubling development for the booming direct-to-consumer orthodontics industry, Byte and its parent company, Dentsply Sirona Inc., are facing a proposed class action lawsuit, claiming its popular at-home teeth alignment products are ineffective and potentially dangerous.

 

The legal action also alleges that the companies engaged in false advertising and deceptive practices while failing to ensure proper oversight from licensed dentists.

 

With hundreds of reported adverse events and serious injuries like tooth loss and gum damage, the lawsuit has significant implications for anyone considering straightening their smile from the comfort of home.

 

Lawsuit Overview 

A Florida patient filed the class action complaint on March 7, 2025, in the U.S. District Court for the Southern District of Florida. 

 

The Byte and Dentsply Sirona lawsuit includes the following key allegations:

  • False advertising and deceptive marketing practices portrayed the Byte aligners as a safe, affordable, and "doctor-directed" solution despite an alleged lack of proper clinical oversight.
  • Failure to sufficiently screen out contraindicated patients, such as those with specific pre-existing dental issues, for whom the at-home aligners could be ineffective or harmful.
  • Hundreds of reported adverse events from October 2020 to October 2024, ranging from minor issues like tooth chipping to more severe problems like gum recession, jaw pain, and tooth loss.

 

The lawsuit hopes to represent a proposed class of all consumers in Florida who purchased a Byte Aligner System and Impression Kit during the relevant period. 

 

More On the Plaintiffs' Allegations

At the heart of the lawsuit are claims that Byte and Dentsply Sirona misled consumers about the safety and efficacy of their direct-to-consumer aligner products. 

 

Aggressive marketing 

According to class plaintiff Paula Phillips, Dentsply Sirona aggressively marketed the Byte system as an affordable, convenient alternative to traditional braces, specifically targeting financially vulnerable individuals with promises of a quick and easy smile transformation.

 

Improper vetting 

However, plaintiffs argue that the company did not subject Byte's products to adequate oversight or review by licensed dentists and orthodontists, contrary to the company's assertions. 

This alleged lack of professional involvement meant that many customers with underlying dental issues, such as gum disease, tooth decay, or previous dental work, received treatment despite being poor candidates for at-home aligners.

 

Mouth and teeth damage

As a result, the lawsuit claims, hundreds of Byte customers suffered a range of injuries and complications, including:

  • Tooth chipping, cracking, and loss.
  • Gum recession and periodontal damage.
  • Jaw pain and misalignment.
  • Worsening of existing dental problems.
  • Allergic reactions to aligner materials.

 

By failing to screen patients and provide proper clinical supervision, the plaintiffs contend that Byte and Dentsply Sirona put profits over consumer health and safety.

 

 

Byte Suspends Sales

The issues with Byte's aligner system reached a turning point in October 2024 when Dentsply Sirona abruptly announced that it was suspending sales, marketing, shipment, and processing of the products pending a review of regulatory requirements.

 

In a message posted on its website, Byte acknowledged that its "patient onboarding workflow may not provide adequate assurance that certain contraindicated patients do not enter treatment," - essentially admitting that some consumers who shouldn't have received aligners ended up using them.

 

Despite this stunning concession, the lawsuit argues that Byte and Dentsply Sirona failed to take appropriate steps to compensate affected customers or offer refunds after halting sales of the aligners. 

 

For many, the damage had already been done.

 

Plaintiff’s Compelling Story

Paula Phillips provided a harrowing account of her experience with Byte aligners in her complaint.

 

A Florida resident and member of The Florida Bar for 28 years, Phillips purchased a Byte Aligner System and Impression Kit for $3,338.02 in April 2024.

 

However, Phillips began experiencing severe pain and bleeding in her mouth within weeks of starting treatment. The symptoms worsened to the point where she had to stop using the aligners. 

 

When she requested a refund, Phillips says Dentsply Sirona told her that no refunds were available due to the nature of the product.

 

Her story underscores the physical, financial, and emotional toll that Byte's allegedly defective and improperly vetted products have taken on trusting consumers.

 

Separate Shareholder Lawsuit

In addition to the consumer class action, Dentsply Sirona is facing legal trouble on another front.

 

In November 2024, securities litigation firm Saxena White filed a separate class action lawsuit for shareholders who purchased the company's stock between December 1, 2022, and November 6, 2024.

 

That complaint alleges that Dentsply Sirona and certain executive officers made false and misleading statements and failed to disclose adverse information about the company's business and operations, particularly related to the Byte aligner products. 

 

The shareholder plaintiffs claim they suffered significant losses due to the alleged misconduct.

 

Risks of DIY Dentistry

The Byte lawsuits highlight the broader dangers of do-it-yourself orthodontics, a trend that has exploded in popularity in recent years. 

 

While at-home aligner companies market their products as a simple, affordable alternative to traditional braces, dental professionals warn that unsupervised teeth straightening can lead to serious oral health problems.

 

According to the American Association of Orthodontists, moving teeth is ”a complex medical process” that requires “careful planning and monitoring” by a trained orthodontist. And attempting to straighten one's teeth without professional guidance can result in “irreversible damage to your gums, bones, and overall bite.”

 

Experts also caution that many people who opt for direct-to-consumer aligners may have underlying dental issues, such as cavities, gum disease, or misaligned jaws, making them poor treatment candidates.

 

Without a thorough in-person examination and X-rays, these problems can go undetected, leading to painful complications.

 

Plaintiffs Want Accountability and Compensation 

The Byte and Dentsply Sirona class action plaintiffs are asking the courts to hold the companies accountable for what plaintiffs describe as a brazen disregard for consumer safety in the pursuit of profits.

 

In addition to monetary damages for physical and financial harm, the complaints demand injunctive relief to halt any further false advertising or sales of the allegedly dangerous aligner products.

 

According to class plaintiff Phillips, “the need for greater public awareness about the potential risks of direct-to-consumer dentistry is urgent.”

 

Your Smile Deserves More Than Convenient Orthodontics

While the convenience and affordability of at-home aligners can be appealing, consumers must thoroughly research any online orthodontic provider and consult with a licensed dentist or orthodontist before starting treatment.

 

With allegations of false advertising, inadequate oversight, and hundreds of adverse patient events, this lawsuit reminds us of the potential dangers of pursuing orthodontic treatment without proper professional supervision.

 

Patients should always protect their oral health and make informed decisions about their care by prioritizing safety and seeking guidance from licensed orthodontic specialists.

Frequently Asked Questions (FAQ)

The Byte Aligners lawsuit alleges that Byte and its parent company, Dentsply Sirona, engaged in false advertising and deceptive practices by marketing their at-home teeth alignment products as safe and effective despite numerous reports of adverse events and injuries like tooth loss and gum damage.

The proposed class action seeks to represent all consumers in Florida who purchased a Byte Aligner System and Impression Kit during the relevant period. However, the lawsuit is still in its early stages, and the court has not yet certified the class.

According to the lawsuit, hundreds of Byte customers have suffered a range of complications and injuries, including tooth chipping and loss, gum recession, jaw pain, allergic reactions, and worsening of existing dental problems. Plaintiffs allege these issues stem from inadequate oversight and review by licensed dentists.

In October 2024, Dentsply Sirona suspended sales and marketing of Byte Aligner products pending a review of regulatory requirements. Byte acknowledged that its patient onboarding process may have allowed some contraindicated patients to receive treatment. However, the lawsuit claims the companies have failed to compensate affected customers adequately.

Dental professionals advise thoroughly researching any direct-to-consumer aligner company and consulting with a licensed orthodontist before starting treatment. While at-home options may be convenient and affordable, unsupervised teeth straightening can lead to serious oral health problems, particularly for those with underlying dental issues.

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