A judge denied the company’s motion to dismiss a class-action lawsuit alleging it misled investors about doctor oversight and failed to report thousands of patient injuries.
A US District Court has largely denied a motion to dismiss a securities fraud class-action lawsuit against Dentsply Sirona and several of its current and former executives. The case centers on allegations that the company misled investors about its since-shuttered Byte direct-to-consumer clear aligner business, specifically concerning the extent of doctor involvement in treatment and the failure to report thousands of serious patient injuries to the Food and Drug Administration (FDA).
Allegations of Insufficient Doctor Oversight
Plaintiffs in the case allege that Dentsply Sirona falsely marketed Byte treatment as “doctor-directed” and “overseen… every step of the way.” According to the January 16, 2026, court filing, the lawsuit claims that patient treatment plans were created by non-dentist “treatment planners in Costa Rica.”
The plans were then sent to remote, US-based dentists for approval through a “four-click” process that could be completed in as little as two minutes. The court filing states that if a dentist rejected a treatment plan, it would be automatically reassigned to another dentist until one approved it. Furthermore, the complaint alleges that ongoing patient care was handled by customer service employees and dental assistants, who were “unequivocally not permitted” to allow patients to speak with a licensed dentist.
The court found that the plaintiffs plausibly argued this system was “not ‘doctor-directed’ in any substantive sense, but rather designed to maximize the number of prescriptions approved without any meaningful input by dentists or orthodontists.”
Failure to Report Patient Injuries
The lawsuit also claims that Dentsply Sirona failed to comply with federal regulations by not reporting thousands of adverse events. According to the complaint, the company tracked “at least 6,894 serious patient injuries” in an internal database called “Trackwise” but did not disclose them to the FDA in a timely manner.
This amounted to a failure to report 97% of injuries that occurred through December 2023, the filing states. The unreported injuries allegedly included tooth fractures, lacerations, and necrosis. Dentsply Sirona began retroactively reporting the backlogged injuries in February 2024 before announcing in October 2024 that it was suspending sales of Byte aligners. The company fully wrote off and shut down the business in February 2025.
Court Upholds Claims Against Most Executives
The court’s ruling allows the case to proceed against the company and most individual defendants, including former chief executive officer Donald Casey and current chief executive officer Simon Campion. The judge dismissed claims against former chief financial officer Jorge Gomez, who departed the company in May 2022, stating the allegations against him were “too attenuated.”
For the remaining executives, the court found sufficient allegations that they had access to information contradicting their public statements, such as through the Trackwise database and quarterly meetings held “to discuss injuries.” The ruling also noted that the departures of three senior executives in mid-2024, as the injury reporting issues began to surface, “bolsters the inference of scienter,” or knowledge of wrongdoing.
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