Four notes:
1. The lawsuit was filed in the U.S. District Court for the Southern District of New York on behalf of all persons and entities that purchased common stock from the dental supplier between Dec. 1, 2022, and Nov. 6, 2024.
2. The 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 its Byte clear aligners.
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.
Becker’s has contacted Dentsply Sirona for comment and will update this article if more information becomes available.
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