Seven notes:
1. Dentsply Sirona acquired Byte, a direct-to-consumer, doctor-directed clear aligner model, in 2021.
2. Dentsply Sirona stated in a news release that it consulted with the FDA in making the decision to suspend Byte sales and marketing.
3. The company has also paused shipment and processing of new and recently placed orders for Byte aligners and impression kits.
4. 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.
5. Byte added in its notice that it believes the potential risk to patients is low.
6. Byte asked current aligner patients with certain conditions to stop treatment and visit a dentist.
7. Dentsply Sirona added that, separate from its review of Byte products, the state regulatory environment has adversely affected the Byte aligner business model. As a result, the company is assessing which resources from Byte may be useful in other business lines.
