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U.S. Department of Health and Human Services

Medical Device Recalls
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 Medical Device Recallssee related information
Date Initiated by FirmNovember 04, 2024
Create DateDecember 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0750-2025
Recall Event ID 95745
ProductBYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.
Recalling Firm/
Manufacturer		 Straight Smile, LLC
3301 N Thanksgiving Way
Lehi UT 84043-4128
For Additional Information ContactMarion Par-Weixlberger
800-877-0020
Manufacturer Reason
for Recall		Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
ActionOn 11/04/2024 and 11/07/2024, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via email to customers informing them of the potential risks associated with BYTE Aligners that the patient onboarding workflow may not provide adequate assurance that patients with active periodontal disease, severe open bite, severe overjet, tooth malocclusion requiring surgical correction, mixed dentition, dental prosthetics or dental implants, or adolescents with skeletally narrow jaws do not enter treatment with BYTE Aligners. The BYTE workflow may not be adequate to identify the conditions for which BYTE Aligners are contraindicated because an in-person exam is not performed. This means that potential patients with one of the above issues may not be appropriately filtered out from treatment. For customers who are actively in treatment. To minimize the risk of illness or injury, we recommend the following: For customers who knowingly suffer from 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, discontinue aligner treatment immediately and visit a dental professional. For all other customers, please promptly visit a dental professional to confirm whether continuing aligner treatment is appropriate for you. Following your dentist visit, please visit https://patient.byte.com/support to upload (i) the name and contact information for the dental professional you visited, (ii) the date visited, and (iii) any visit notes provided by the dental professional during your visit. BYTE will reach out to you to gather a signed consent to enable us to gather other information needed from such dental professional. For questions/concerns - contact treating dentist by submitting a support request through Patient Account Center (https://patient.byte.com/support), the My Byte App, or calling Byte support (877) 298-36
Quantity in Commerce5,324,178 devices
DistributionWorldwide - U.S. Nationwide distribution including in the states of CO, KS, MI, IL, GA NY, MN, IN, PA, TX, NJ, MS, RI, SD, FL, KY, CA, OR, WI, WY, MA, NC, WA, AR, UT, OH, SC, NM, CT, TN, LA, NE, AL, MO, VA, MD, IA, OK, NV, DE, VT, AZ, RI, HI, WV, NH, MT, AK, ID, Puerto Rico, ME and the countries of Australia.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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