On Thursday, Dentsply Sirona said it has suspended sales and marketing of its teeth aligners — Byte Aligners and Impression Kits — following a voluntary decision made in consultation with the U.S. Food and Drug Administration (FDA) to ensure compliance with U.S. regulations.
“The company holds itself to the highest standards of quality, with patient safety at the centre of everything we do,” it said in a press release.
Dentsply Sirona said it will continue to work with the FDA and other regulatory authorities while communicating with treating dentists and their patients.
Additionally, changes in state regulations across the U.S. have made it more challenging for the company to sell these products. The company did not provide specific details about the new requirements.
Dentsply Sirona has begun reallocating resources from Byte to other areas of its business. “We had begun to assess our resources at Byte to leverage and/or redeploy infrastructure, talent, and capability elsewhere in our business,” it said. “Examples include augmenting resources to improve other software platforms, accelerating DS Core functionality, and enhancing the patient experience.”
The company emphasized that the suspension only applies to the Byte business. Its other aligner business, such as SureSmile, remains unaffected.
The company also provided preliminary third-quarter results, expecting to report net sales of about $951 million and an adjusted profit of between 49 and 51 cents per share. According to data compiled by LSEG, analysts had forecasted sales of $937.91 million and adjusted profit of 47 cents per share.
