05:02 AM EDT, 10/25/2024 (MT Newswires) -- Dentsply Sirona ( XRAY ) said late Thursday it has voluntarily suspended sales and marketing of its Byte Aligners and Impression Kits, pending a review of regulatory requirements.
The company said the decision was made in consultation with the US Food and Drug Administration and that it will continue to work closely with regulators while maintaining support to existing patients.
Dentsply Sirona ( XRAY ) has started the process of reviewing its resources at Byte due to the adverse impact of the regulatory environment on its Byte Aligner business model, the company said.
Additionally, Dentsply expects to report Q3 adjusted earnings of between $0.49 and $0.51 per share and net sales of around $951 million.
Analysts polled by Capital IQ expect $0.47 earnings per share and sales of $939.7 million.
The company also said it expects to book a goodwill impairment charge of $450 million to $550 million, primarily driven by adverse impacts from state regulatory trends pertaining to its Byte Aligner business and weaker demand and pricing pressures for its implants and prosthetic business.
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