Summary: Dentsply Sirona has paused sales and marketing for Byte Aligners and Impression Kits to review regulatory requirements. Challenges from the regulatory environment have impacted Byte’s business, prompting the company to assess resource reallocation within its operations.
Key Takeaways:
- Dentsply Sirona is conducting a regulatory review of Byte products in consultation with the FDA, suspending new orders and shipments temporarily.
- Regulatory challenges have led to a re-evaluation of Byte’s resources, with plans to redeploy infrastructure to other business areas.
Dentsply Sirona announced a voluntary suspension of sales and marketing for its Byte Aligners and Impression Kits to conduct a review of regulatory requirements. This decision was made in consultation with the U.S. Food and Drug Administration (FDA).
Suspension of Shipments and Order Processing
As part of the review, Dentsply Sirona has suspended shipment and processing of new and recent orders for Byte Aligners and Impression Kits. The company emphasized its commitment to high standards of quality and patient safety and will work closely with the FDA and regulatory authorities throughout this process. Dentsply Sirona is also communicating with dentists and patients to support ongoing care as needed.
Challenges in the Regulatory Environment
Dentsply Sirona noted that the state regulatory environment has impacted its Byte Aligner business model, with new documentation, records, and additional requirements—such as patient x-rays and evidence of visits to a dentist—affecting conversion rates. Due to these challenges, the company has been evaluating ways to reallocate resources at Byte to enhance other business areas, such as software platform improvements, accelerating DS Core functionality, and enhancing patient experiences.
Next Steps for Byte
The company will continue to evaluate Byte’s future, aiming to provide quality oral care access to underserved populations.
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