Subsequent Events

9 Months Ended

Sep. 30, 2024

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

On October 24, 2024, the Company announced the voluntary suspension of the sale and marketing of its Byte aligner system and impression kits, while the Company conducts a review of certain regulatory requirements related to these products. The Company’s decision was made in communication with the U.S. Food and Drug Administration (the “FDA”). In connection with this review, and the Company’s proactive efforts to continuously improve its processes, the Company has suspended shipment and processing of new and recently placed orders for Byte aligners and impression kits. The Company expects this suspension of sales to have a material impact on the Company’s results of operations. The sales of Byte aligner systems and impression kits represent approximately 5% of the Company’s revenue for the nine months ended September 30, 2024, and the assets related to the Byte aligner business are approximately 6% of the Company’s assets at September 30, 2024. The Byte aligner business is included within the Orthodontic and Implant Solutions operating segment.

While the Company is evaluating and assessing the appropriate next steps, the Company is unable to estimate the timeframe or provide any assurances that it can return Byte aligners and impression kits to the market. The results of this review may also require the Company to further change or discontinue its current business model and operations of its direct-to-consumer aligner business, which could result in a greater material adverse impact on the Company’s business, financial condition, and results of operations, including asset impairments. In addition, the Company’s failure to promptly resolve these issues or to comply with the U.S. medical device regulatory requirements in general could result in regulatory action being initiated by the FDA that would have a material adverse impact on the Company’s financial status and results of operations. The FDA’s actions could include, among other things, fines, injunctions, consent decrees, civil money penalties, repairs, replacements, refunds, recalls or seizures of products, total or partial suspension of production, the FDA’s refusal to grant future premarket approvals and criminal prosecution.