SouSmile
Numbers are the ones on SouSmile's own site, read Nov 13, 2026. WhatsApp opens your own chat with a first line you can change that names this site; nothing you write reaches us.
SouSmile is Brazil's largest homegrown clear-aligner brand (founded 2018, headquartered in Sao Paulo), running a hybrid model: a virtual pre-assessment, then an in-clinic 3D scan and panoramic X-ray at one of 500+ points of care backed by 2,000+ credentialed partner dentists, with each plan designed by its orthodontists and monitored remotely via app. It manufactures its own polyurethane aligners in Sao Paulo. SouSmile does not publish plan prices on its site (it quotes each patient after a pre-assessment); plans include all aligner stages, one pair of retainers and regular in-person check-ups, with remote monitoring. Typical treatment runs about 7 months (Light), 12 months (Smart) or 18 months (Plus), and whitening can be applied through the trays. 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.
At a glance
Prices verified Nov 12, 2026SouSmile (SouSmile Light, SouSmile Smart, SouSmile Plus) is a clear aligner brand available to new patients that has no FDA device recall on file. Treatment is hybrid (remote care with an in-person clinic option).
- Treatment length
- 3-9 monthstypical
- Supervision
- Hybrid
- FDA safety
- No recalls
- Starting price
What it can treat
In SouSmile's own words: Mild-to-moderate crowding and misalignment; Spacing and gaps; Bite correction in select cases; Cosmetic smile alignment. Sources
A series of custom clear polyurethane trays (SouSmile's own aligner, 3D-printed at its Sao Paulo factory), each worn all day for about two weeks to move teeth incrementally. The plan is built by SouSmile orthodontists from an in-clinic 3D intraoral scan and panoramic X-ray taken after a virtual pre-assessment, then monitored remotely through app photo scans every two weeks (reviewed by AI and dentists) plus in-person clinic check-ups roughly every three months. 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 “SouSmile” 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
Remote care day to day, with a clinic scan or check-up available when you want one. Suits: at-home convenience with a clinician you can see in person.
SouSmile: Dentist-led hybrid: plans designed by SouSmile orthodontists (clinical team described as predominantly orthodontists with 10+ years of aligner experience); the patient submits an app scan every 2 weeks (AI plus dentists review progress) and attends in-person clinic check-ups roughly every 3 months Sources
Brand specs
- Retainers
- One pair of retention plates (contencao) included; worn full-time for about 3 months, then nightly
- Refinements / touch-ups
- Unlimited refinements at no extra cost at the end of treatment, provided the patient meets the minimum app photo-monitoring compliance
- HSA / FSA
- Not applicable (Brazil)
- Headquarters
- Sao Paulo, Brazil (Pinheiros; Av. Reboucas 3970)
Clear aligners are FDA Class II devices (product code NXC, 21 CFR 872.5470), cleared through the 510(k) process. SouSmile treatment is hybrid (remote care with an in-person clinic option).
Where the SouSmile 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.
- sousmile.comhttps://www.sousmile.com/preco/
- sousmile.comhttps://www.sousmile.com/aparelho-transparente/como-funciona/
- sousmile.comhttps://www.sousmile.com/termos-uso/
- sousmile.comhttps://www.sousmile.com/quem-somos/
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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
Ways to start SouSmile
Every way to start, lowest price first.
SouSmile costs Quoted after assessment (not published) via SouSmile, hybrid (online + clinic), 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 SouSmile
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).