Three notes:
1. Dentsply Sirona voluntarily suspended the sale and marketing of its Byte clear aligners and impression kits Oct. 24 as it conducts a review of regulatory requirements. It also paused shipment and processing of new and recently placed orders for Byte aligners and impression kits.
2. Byte said in an Oct. 25 notice posted on its website that it determined its patient onboarding workflow “may not provide adequate assurance that certain contraindicated patients do not enter treatment with Byte aligners.” This conclusion came from a review of medical device reports related to its aligners and discussions with the FDA.
3. Bronstein, Gewirtz & Grossman said Oct. 31 it is investigating potential claims on behalf of Dentsply Sirona’s investors.