A proposed class-action lawsuit was recently filed against Dentsply Sirona and Byte, alleging breaches of contract and implied warranty, false advertising and deceptive practices.
Eight notes on the lawsuit:
1. The lawsuit was filed March 7 and seeks to cover consumers in Florida who purchased a Byte Aligner System and Impression Kit.
2. The lawsuit alleges that the companies’ advertisements targeted “financially vulnerable victims” as an affordable and accessible option to improve smiles, despite the clear aligners allegedly being proven to be “ineffective and dangerous to consumers.”
3. Dentsply Sirona voluntarily suspended the sale and marketing of its Byte clear aligners and impression kits Oct. 24 while reviewing regulatory requirements. The company also paused shipment and processing of new and recently placed orders for the products.
4. 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.
5. 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.
6. The lawsuit aims to rectify alleged damages that class members have suffered and to stop the further sales of the aligners.
7. Securities litigation firm Saxena White filed its own class-action lawsuit in November on behalf of all persons and entities that purchased common stock from the dental supplier between Dec. 1, 2022, and Nov. 6, 2024.
8. Saxena White’s lawsuit alleges that Dentsply Sirona and certain executive officers made false and misleading statements and failed to disclose adverse information about its business, operations and prospects, particularly related to the Byte clear aligners.
Dentsply Sirona told Becker’s it does not comment on pending investigations or lawsuits.
