A federal judge largely denied a motion to dismiss a proposed class-action lawsuit against Dentsply Sirona for its Byte aligners, A&O Shearman reported in a Jan. 27 JD Supra article. Dentsply Sirona voluntarily suspended the sale and marketing of its Byte clear aligners and impression kits in October 2024 while reviewing regulatory requirements. Byte disclosed in a notice on its website that its patient onboarding workflow “may not provide adequate assurance that certain contraindicated patients do not enter treatment with Byte aligners.” This conclusion followed a review of medical device reports related to its aligners and discussions with the FDA. A class-action lawsuit was filed on behalf of those who purchased or acquired Dentsply Sirona securities, alleging that Dentsply Sirona made misleading statements and omissions regarding its business, financial condition and prospects. The lawsuit also alleges that Dentsply Sirona sold Byte aligners to contraindicated patients knowing that the aligners were injuring patients.