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RecallWatchMedical Device Safety
Class IIOngoingZ-0750-2025

Straight Smile, LLC recalls BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner…

Straight Smile, LLCLehi, UT, United StatesReported Jan 1, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

BYTE 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.

Lot / code information

Catalog #
PRS-0063
UDI
code: 00850017524163
Lot #
U.S. 17732803613 1541-8760994451 1543-1100754821 1543-3414202891 1543-3432526751 1543-4235973091 1543-6917440011 1543-9520827111 1544-3697240661 1544-3701204981 1544-5456199651 1544-7224133161 1544-90…Show all
U.S. 17732803613 1541-8760994451 1543-1100754821 1543-3414202891 1543-3432526751 1543-4235973091 1543-6917440011 1543-9520827111 1544-3697240661 1544-3701204981 1544-5456199651 1544-7224133161 1544-9091272701 1544-9711007881 1545-1892023561 1545-2829643331 1545-8723173781 1546-0149254981 1546-1844697261 1546-2431084621 1546-4535565811 1546-5302658721 1547-4352731881 1547-5049030711 1548-0962989131 1548-7930768331 1548-8608483691 1549-0109064461 1549-3476145071 1549-3914331141 1549-5604271371 1549-6288071031 1549-7431308041 1549-8157978931 1549-9114511321 1549-9463103781 1550-0849217361 1550-1755809801 1550-1808153641 1550-2472171981 1550-2742615371 1550-5987393421 1550-7942491181 1550-8978597191 1551-1922835701 1551-3703690751 1551-4047563861 1551-4819077851 1551-4826159631 1551-6464211451 1551-6492468971 1551-9010332821 1551-9847531111 1552-0753888851 1552-4909407241 1552-6104081791 1552-6878824261 1552-8348951001 1552-9637841291 1553-2183553251 1553-2206830171 1553-2207770561 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1573-8560919201 1573-9242953811 1573-9438493441 …
Additional code information

313301 1593-4413804701 1593-4430862681 1593-4436760641 1593-4449281471 1593-4457729811 1593-4497345211 1593-4590642601 1593-4606354621 1593-4623544971 1593-4629694171 1593-4708129371 1593-4735243541 1593-4749125161 1593-4854075071 1593-5129424661 1593-5153386141 1593-5164839121 1593-5169033101 1593-5334846761 1593-5338977511 1593-5397626431 1593-5398288411 1593-5411583071 1593-5474359851 1593-5503131201 1593-5546560911 1593-5559616361 1593-5560948041 1593-5653265011 1593-5699536801 1593-5704194881 1593-5830116951 1593-5844384431 1593-5979935941 1593-6029637441 1593-6119805141 1593-6135384681 1593-6169156331 1593-6220032121 1593-6227892361 1593-6245525251 1593-6257837351 1593-6260134501 1593-6264721491 1593-6273745481 1593-6281049321 1593-6286156371 1593-6292317961 1593-6299040121 1593-6318539171 1593-6343361951 1593-6353879061 1593-6491379011 1593-6552543311 1593-6763023191 1593-6806600401 1593-6877559991 1593-6908750161 1593-6928337101 1593-6960301741 1593-7049752541 1593-7052603691 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1595-8863186541 1595-8893197971 1595-8902299951 1595-8907215051 1595-8931808801 1595-8933988421 1595-8939411831 1595-9012630791 1595-9071425431 1595-9140711731 1595-9162719611 1595-9267851571 1595-9285730781 1595-9316165351 1595-9351557571 1595-9419369801 1595-9449005781 1595-9460693411 1595-9464668571 1595-9481395931 1595-9485818681 1595-9486179041 1595-9500602431 1595-9525916031 1595-9528907371 1595-9530340291 1595-9542361351 1595-9577135271 1595-9583004981 1595-9590584861 1595-9593080291 1595-9605043481 1595-9623210461 1595-9623568591 1595-9624388301 1595-9649935781 1595-9663784961 1595-9796284331 1595-9811209571 1595-9843528811 1595-9870165821 1595-9892771511 1595-9899822271 1595-9908591611 1595-9920987841 1596-0009613571 1596-0344625791 1596-0410438121 1596-0441570801 1596-0492452061 1596-0566261211 1596-0593700281 1596-0612710701 1596-0644069441 1596-0651193501 1596-0653739191 1596-0690322501 1596-0742684431 1596-0769214981 1596-0772292591 1596-0809094511 1596-0840185091 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1596-6370000701 1596-6375582201 1596-6409227811 1596-6430009851 1596-6475601931 1596-6476 …

What the firm is doing

On 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

DistributionShow details

Worldwide - 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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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