Recall Z-0750-2025 ยท NXC Aligner, Sequential
Straight Smile, LLC
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.
| Date | Dec 23, 2024 (initiated Nov 4, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 5,324,178 devices |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230199 | Byte Aligner System Dentsply Sirona, Inc., Oct 18, 2023 |