A US District Court has largely rejected a bid by Dentsply Sirona and several current and former executives to dismiss a securities fraud class-action lawsuit tied to the company’s now-closed Byte clear aligner business.
In a ruling dated January 16, 2026, the court found that investors plausibly alleged the company misled the market about the level of doctor involvement in Byte treatments and failed to properly report thousands of serious patient injuries to the Food and Drug Administration (FDA).
According to the complaint, Dentsply Sirona marketed Byte as a “doctor-directed” clear aligner product with treatment “overseen… every step of the way.” Plaintiffs allege that, in practice, treatment plans were created by non-dentist planners in Costa Rica.
Those plans were then sent to US-based dentists for approval through what the lawsuit describes as a “four-click” process that could take as little as two minutes. If a dentist rejected a plan, it was allegedly reassigned to another dentist until approved.
The filing further claims that ongoing patient care was handled by customer service staff and dental assistants, who were not allowed to connect patients with licensed dentists. The judge said these allegations support a reasonable inference that the system was “not ‘doctor-directed’ in any substantive sense,” but instead designed to maximize prescription approvals with minimal professional oversight.
The lawsuit also accuses the company of violating federal reporting rules by failing to disclose adverse events linked to Byte aligners. Plaintiffs allege Dentsply Sirona tracked at least 6,894 serious patient injuries in an internal system known as “Trackwise” but did not report most of them to the FDA.
The unreported cases, which the complaint says represented about 97% of injuries through December 2023, allegedly included tooth fractures, lacerations, and tissue necrosis. Dentsply Sirona began submitting delayed reports in February 2024 and later suspended Byte aligner sales in October 2024. The company fully wrote off and shut down the business in February 2025.
The court allowed claims to proceed against Dentsply Sirona and most individual defendants, including former CEO Donald Casey and current CEO Simon Campion. Claims against former chief financial officer Jorge Gomez, who left the company in May 2022, were dismissed as too remote.
For the remaining executives, the judge found sufficient allegations that they had access to information contradicting public statements, including data in the Trackwise system and quarterly meetings held to discuss injuries. The court also noted that the mid-2024 departures of three senior executives, as reporting issues emerged, strengthened the inference that company leaders knew about the alleged problems.