Dental technology company Dentsply Sirona is repositioning Byte within its aligner portfolio and expanding in-person dentist oversight for the clear aligner brand.
Five 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. Dentsply Sirona said Jan. 14 it plans to shift its Byte business model to include more in-person dentist oversight, and leverage "collaborative direct-to-consumer demand generation with dentists."
4. The company added that it would not be reinstating its at-home Byte systems and impression kits but will continue to provide support for non-contraindicated patients currently undergoing treatment.
5. The dental technology company said it will also continue to work with regulatory authorities and obtain necessary clearances prior to any market launch.