Dental products manufacturer Dentsply Sirona has voluntarily suspended the sale and marketing of its Byte aligners and impression kits while it conducts a review of regulatory requirements, according to a company press release dated October 24.
Dentsply Sirona suspended the sales and marketing of the Byte aligners, as well as the shipping and processing of new and recently placed orders, after consulting with the U.S. Food and Drug Administration (FDA).
Furthermore, the company stated that the decline in fair value of its aligners has been driven primarily by adverse effects from recent state regulatory trends pertaining to Dentsply Sirona's direct-to-consumer aligner business, according to the company's recent filing with the Securities and Exchange Commission (SEC). Regulations requiring proof of dental visits, patient x-rays, and other documentation have affected the company's model.
Approximately 5% of Dentsply Sirona's annual revenue comes from its aligners and kits. Failure to promptly resolve issues or comply with U.S. medical device regulatory requirements could result in regulatory action, including criminal prosecution, fines, civil penalties, recalls, and product seizures, from the FDA. These actions would have material adverse effects on Dentsply Sirona's financial status and operations, according to the SEC filing.
Therefore, Dentsply Sirona is continuing to work with the FDA and other regulatory bodies on these issues. Also, the company has started to assess resources at Byte to leverage and/or redeploy infrastructure, talent, and capability elsewhere within the business, according to the release.
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