Lifshitz Law has launched an investigation into Dentsply Sirona for possible securities laws violations and breach of fiduciary duties by certain company executives.
Five notes:
1. Dentsply Sirona voluntarily suspended the sale and marketing of its Byte clear aligners and impression kits last October while reviewing regulatory requirements.
2. Byte disclosed in an Oct. 25 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.
3. Dentsply Sirona announced in January that it would reposition Byte within its aligner portfolio and expand in-person dentist oversight for the clear aligner brand.
4. The Lifshitz Law investigation is in connection with allegations that Dentsply Sirona made materially false and/or misleading statements and failed to disclose certain information, including information that led to contraindicated patients being sold Byte products.
5. Multiple class-action lawsuits were filed against Dentsply Sirona in recent months in connection with the Byte suspension.
