Straight Smile, LLC recalls BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodont

Recalled January 1, 2025 · FDA recall Z-0750-2025 · Straight Smile

Hazard

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. · FDA Class II

Units

5,324,178 devices

Sold at

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.

Description

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.

Product

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.

Manufacturer(s)

Straight Smile, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →