Dear Valued Customer,
Patient safety is at the center of everything Byte does. We hold ourselves to the highest standards of quality and compliance and will collaborate and communicate with key stakeholders, including treating physicians and their patients as we evaluate and assess next steps. Our goal is to continue supporting treating doctors and their patients to provide quality oral care.
During review and discussion of a subset of medical device reports related to our Byte Aligner product, and through our communication with the FDA, we have determined that our patient onboarding workflow may not provide adequate assurance that certain contraindicated patients do not enter treatment with Byte Aligners.
While we continue to believe the potential risk to patients remains low, we made the decision to voluntarily pause shipment and processing of new and recently placed orders for Byte Aligners and Impression Kits while we perform a more comprehensive review.
If you are currently in Byte Aligner treatment and have known active periodontal disease, severe open bite, severe overjet, tooth malocclusion requiring surgical correction, mixed dentition, have dental prosthetics or dental implants, or are an adolescent with a skeletally narrow jaw, please stop treatment. We also recommend that you visit a dentist to review your overall oral health.
All other patients, please continue per your treatment plan, and if you have any questions, please contact your Byte treating dentist by submitting a support request through your Patient Account Center (https://patient.byte.com/support) or the My Byte App.
At this time, we do not have additional details to share, but we will be communicating further with customers as new information becomes available. We expect more information to be available at www.byte.com in the coming days.
Thank you for your understanding. We recognize that this may be an inconvenience, but we remain committed to providing you a safe and effective product. If you have further questions or need assistance, please don’t hesitate to reach out.