Byte Aligners Lawsuit Says Dental Products Are Ineffective, Dangerous

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A proposed class action lawsuit alleges Byte Aligner Systems and Impression Kits are falsely advertised in that the purported smile-fixing products, sales of which were suspended last year, have been proven to be ineffective and dangerous.

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The 25-page class action suit says that sales of the Byte Aligner System and Impression Kits were abruptly halted in October 2024 amid a “review of certain regulatory requirements” for the purportedly cost-effective products by defendants Straight Smile LLC and Dentsply Sirona Inc. 

The filing alleges that although the defendants claimed that use of the aligners and their associated treatment plans are overseen by a nationwide network of licensed dentists and orthodontists, and that no initial assessment by a dental professional is necessary for the purchase or use of the impression kit or aligners, the products, in truth “were not sufficiently overseen, reviewed, or directed by a medical professional.” 

According to the lawsuit, from October 2020 to October 2024, there were “hundreds of incidents involving adverse events” linked to the Byte Aligner products, including allergic reactions, bite misalignment, bone loss, broken or chipped teeth, choking due to poorly fitting aligners, facial swelling, worsening bite, gum recession, locked jaw, loosening of teeth and veneers, tooth discoloration, pulp necrosis and more. 

“That the Products are associated with this many medical conditions indicates how, contrary to Defendants’ representations, they lacked sufficient medical oversight of the Products,” the class action suit alleges. “Additionally, the [sic] demonstrate that, contrary to Defendants’ representations, the Products were not safe and effective in the treatment of misaligned teeth.” 

The class action lawsuit accuses Byte and Dentsply of purposely targeting lower-income consumers with the products, openly admitting to aiming for “disadvantaged socio-economic groups” by stating online that a straighter smile “was once only reserved for certain groups of people.” 

Though the suspension of sales of the Byte dental products was “widely reported in the press,” the defendants failed to make customers whole after selling them products “based on false and deceptive representations,” the lawsuit claims. Further, the defendants have allegedly failed to put in place a reporting system by which to channel consumer complaints to regulators. 

In a message posted to its website on October 25, 2024, Byte stated that it made the decision to voluntarily pause shipment and processing of new and recent orders after determining its patient onboarding process failed to assure that certain “contraindicated patients” do not enter treatment with the aligners, the lawsuit relays. The message went on to recommend that customers with certain adverse dental conditions visit a dentist to review their overall oral health. 

“Even though Defendants’ business model is premised on advertising that Defendants’ Products are more cost effective than traditional clear aligners requiring costly and time consuming in-office medical appointments, Defendants’ October 25, 2024, press release admits that customers will need to incur the costs and time to visit doctors,” the lawsuit reads, noting that, in the months since the message has been posted, the defendants have provided no additional material information to customers. 

The lawsuit states that despite the foregoing “concerning admissions” by the defendants, and despite the statement that new and recently placed orders were paused, the companies continue to market, advertise and sell the Byte Aligners and Impression Kit. 

The Byte Aligners lawsuit looks to cover all consumers in Florida who bought a Byte Aligner System and Impression Kit. 

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