2USmiles
Low-priced US at-home brand: daytime $1,195 with the current discount (list $1,495) and nighttime $1,345 (list $1,645), or monthly plans from $104/mo after a $399 down payment, with a $9.95 impression kit. Flagged by reviewers for mixed reviews; the FDA issued its maker a Warning Letter in June 2023 and a close-out letter in July 2024. Sources
Sourced from each brand's published terms and primary FDA device records. Prices checked against their sources Nov 12, 2026, FDA records read Nov 10, 2026. How we verify. Not dental or medical advice.
The FDA issued 2U Smiles a Warning Letter in June 2023 citing unapproved (not cleared/approved) treatment-planning software and quality-system violations. In July 2024 the FDA closed it out, stating the company appears to have addressed the violations and that future inspections will assess whether the corrections are adequate and sustained. Worth knowing for a remote, exam-free model. Sources
At a glance
Prices verified Nov 12, 20262USmiles (2USmiles Aligners) is a clear aligner brand available to new patients that has no FDA device recall on file. Treatment is fully remote (mail-order, reviewed online).
- Treatment length
- 4-8 monthstypical
- Supervision
- Remote
- FDA safety
- No recalls
- Starting price
- Wear schedule
- All-day (~22 hrs) or night-only
What it can treat
In 2USmiles's own words: Mild-to-moderate crowding; Spacing and gaps. Sources
A remote at-home system: custom trays from a mailed impression, with photos/impressions reviewed by a dental professional and no X-rays or in-person exam. Sources
Safety & recalls
This brand's FDA device record under the aligner product code NXC: recalls and MAUDE adverse-event reports, verified Nov 10, 2026.
A raw count of unverified FDA reports filed under “2USmiles” and product code NXC, not a rate. None on file may reflect how new or small the brand is, not proof of safety. Every brand's count is on the safety board.
Read from the FDA's database every day, last on Nov 10, 2026. Unchanged since we first recorded it on Sep 30, 2026.
How treatment is supervised
Impressions or a scan kit at home, a plan reviewed online, aligners mailed to your door. Suits: mild crowding or spacing, when you are comfortable with no in-person exam.
2USmiles: Fully remote; a dental professional reviews photos/impressions (credentials not always disclosed), no X-rays or in-person exam. FDA Warning Letter (June 2023) over unapproved treatment-planning software and quality-system violations, closed out by the FDA in July 2024 Sources
Brand specs
- Start method
- At-home impression kit ($9.95)
- Material
- BPA-free clear plastic
- Retainers
- Retainers bundled with the plan
- Whitening
- Whitening bundled with the plan
- Refinements / touch-ups
- Not prominently published
- Guarantee
- Not prominently published
- Financing
- Monthly payment plans
- HSA / FSA
- Not published
- Insurance
- Not published
- Availability
- United States
- Headquarters
- United States
- Wear schedule
- All-day (~22 hrs) or night-only
Clear aligners are FDA Class II devices (product code NXC, 21 CFR 872.5470), cleared through the 510(k) process. 2USmiles treatment is fully remote (mail-order, reviewed online).
Where the 2USmiles facts come from
The pages behind this brand's profile, specs and supervision model. Prices, treatment length and FDA records each link to their own source where they appear.
- newmouth.comhttps://www.newmouth.com/orthodontics/treatment/clear-aligners/2usmiles/
- 2usmiles.comhttps://www.2usmiles.com/
Work at 2USmiles? Correct this listing or set up a referral link
Safety notices for at-home aligners
Regulatory safety findings a current reference should carry, even when the live per-brand feed has not caught up. Each is cited and dated.
Dental bodies caution against straightening teeth without an in-person exam
The American Dental Association maintains a standing policy discouraging direct-to-consumer teeth straightening, reaffirmed in December 2023 on patient-safety grounds. The American Association of Orthodontists holds that treatment should be under the in-person supervision of a licensed orthodontist, warns that moving teeth without an exam and X-rays can miss gum disease or cavities and cause irreversible, expensive harm (bone and tooth loss, receding gums, changed bites), and urges patients to report problems to the FDA. See a dentist before starting, and stop and seek care if you notice pain, looseness, or bleeding.
American Dental Association; American Association of Orthodontists · as of Dec 1, 2023
Reported harms in the FDA device adverse-event database
Thousands of adverse-event reports have been filed with the FDA under the sequential clear-aligner product code (NXC), the large majority coded as injuries, spanning both in-office and at-home brands. A peer-reviewed analysis of the NXC reports filed from 2010 to 2020 (651 reports, 104 of them involving direct-to-consumer aligners) found the direct-to-consumer reports dominated by bite problems (41.3%), orofacial pain (29.8%) and periodontal harm (26.6%) such as loose teeth, gum recession and bone loss, with tooth sensitivity, jaw (TMJ) problems, fractured teeth and tooth loss also reported; the authors note that some of these harms are irreversible. These are unverified spontaneous reports, not incidence rates, and do not establish that any device caused the event, but they underline why an in-person check and professional oversight matter.
Belgal et al., Dentistry Journal 2023 (analysis of FDA MAUDE reports, product code NXC) · as of Sep 30, 2026
2USmiles: 2023 FDA Warning Letter over an uncleared treatment-planning change and misleading FDA claims (closed out in 2024)
In June 2023 the FDA issued Vitang Technology LLC (which operates the 2USmiles / UniSmile clear-aligner system) a Warning Letter after an inspection: the company had switched the device's treatment-planning software from the FDA-cleared Orchestrate 3D to the non-cleared iRok OrthoRx 4.0 without submitting a new 510(k), its website carried misleading "FDA APPROVED" claims and the FDA logo, and the inspection also found quality-system violations. On July 23, 2024 the FDA issued a close-out letter stating that the company appears to have addressed the violations, while noting that future inspections will assess whether the corrections are adequate and sustained. 2USmiles remains a low-cost, fully remote (exam-free) brand selling to new patients.
U.S. Food & Drug Administration (Warning Letter 653455 and its July 2024 close-out letter) · as of Jul 23, 2024
Ways to start 2USmiles
Every way to start, lowest price first.
2USmiles costs from $104/mo via 2USmiles, brand direct (at-home), across 1 tracked way to start.
Prices are each brand's stated starting figure, not the total cost. They change often; each links to its source. Re-verified 2026-11-12. This is information, not dental or medical advice.
Clinical evidence & professional guidance
No registered study names 2USmiles
Independent clinical evidence on individual aligner brands is limited, and both the American Dental Association and the American Association of Orthodontists advise an in-person exam and dentist or orthodontist supervision before treatment. The clear aligner studies we index cover the category as a whole (134 registered on ClinicalTrials.gov).