Dentsply Sirona Suspends Sales, Marketing for Byte Aligners

Dentsply Sirona has voluntarily suspended sales and marketing of its Byte aligners and impression kits.
 
The suspension was announced as the company conducts a review of certain regulatory requirements related to those products. The decision was made in consultation with the U.S. Food and Drug Administration (FDA). Dentsply has also suspended shipment and processing of new and recently placed orders for Byte aligners and impression kits.
 
The company acquired Byte and its clear aligner tech in a $1.04 billion, all-cash deal in 2021.
 
The company holds itself to the highest standards of quality and compliance with patient safety at the center of everything we do,” Dentsply Sirona said in a press release. “To that end, we will continue to work closely with the FDA and other regulatory authorities, while communicating with treating dentists and their patients to support their continued care as appropriate.”
 
The company said that independent of the matter, the state regulatory environment adversely impacted its Byte aligner business model. It cited declining conversion rates, new documentation, records, and additional requirements. Because of this, Dentsply Sirona began assessing its resources at Byte.
 
The company may start to leverage and/or redeploy infrastructure, talent, and capability elsewhere in its business. Examples include augmenting resources to improve other software platforms, accelerating DS Core functionality, and enhancing the patient experience.
 
“The company will evaluate and assess the appropriate next steps for Byte, with the goal of continuing to provide access to quality oral care to underserved populations,” Dentsply Sirona said. “In connection with this assessment, the company may incur additional impairments and write-offs regarding this business, which may be material in the current and future periods.