Three notes:
1. 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.
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. The Kessler Topaz Meltzer & Check law firm’s investigation comes after similar probes announced earlier this month by Pomerantz and Bronstein, Gewirtz & Grossman.
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