SmileSet
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SmileSet is a US direct-to-home clear aligner brand launched in January 2024 as a distinct successor built on manufacturing and treatment-planning technology and 100+ patents acquired from SmileDirectClub after SDC ceased operations in 2023. The patient starts with a mailed at-home impression kit (a free in-person 3D scan is also offered at SmileStudio locations), then US-licensed dentists remotely prescribe and monitor a custom aligner series with no required office visits. Complete treatment lists at $1,895 and is discounted to $1,395, with financing advertised from about $87 per month, FSA/HSA eligibility, and a 30-day money-back guarantee after starting treatment. All-day aligners typically take 4-6 months and a nighttime (about 10-hour) option 6-9 months. The operating entity is reported as OrthoTech, LLC (owner David Katzman, an SDC co-founder), BBB-listed and accredited in Antioch, Tennessee, and it explicitly does not honor former SmileDirectClub guarantees or warranties. Sources
Sourced from each brand's published terms and primary FDA device records. Prices checked against their sources Nov 11, 2026, FDA records read Nov 10, 2026. How we verify. Not dental or medical advice.
On sale now: Early Black Friday access, an extra 20% off the whole order with code BiggerSmile20 (seen on SmileSet's page Nov 12, 2026).
Available to new US patients as of 2026. A newer brand (launched January 2024) that is a distinct legal entity from the defunct SmileDirectClub; it acquired select SDC technology and patents but did not assume SDC liabilities and does not honor former SmileDirectClub guarantees or warranties (per SmileSet's own former-SDC-customers page). Sources
At a glance
Prices verified Nov 11, 2026SmileSet (SmileSet All-Day Aligners, SmileSet Nighttime 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
- 4-6 monthstypical
- Supervision
- Remote
- FDA safety
- No recalls
- Starting price
What it can treat
In SmileSet's own words: Mild-to-moderate crowding; Spacing and gaps between teeth; Minor cosmetic misalignment and relapse. Sources
A series of custom clear thermoplastic aligner trays made from an at-home dental impression (or an in-person 3D scan), each worn in sequence to move teeth incrementally toward the planned position. Treatment is prescribed and monitored remotely by US-licensed dental professionals with no required in-office visits (teledentistry). SmileSet describes its appliances as FDA-cleared and 100% US-manufactured. The specific aligner material composition is not published in detail on the brand's site. 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 “SmileSet” and product code NXC, not a rate. Larger and older brands accumulate more. Every brand's count is on the safety board.
Read from the FDA's database every day, last on Nov 10, 2026. Up from 10 on Sep 30, 2026, the first count we recorded.
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.
SmileSet: US-licensed dental professionals prescribe and remotely review and monitor each plan (teledentistry); no in-person visit required Sources
Brand specs
- Whitening
- Not published
- Refinements / touch-ups
- Not published (refinement and retreatment policy not disclosed on public materials)
- Clinical oversight
- US-licensed dental professionals prescribe and remotely review and monitor each plan (teledentistry); no in-person visit required
- HSA / FSA
- FSA/HSA eligible
- Availability
- United States
Clear aligners are FDA Class II devices (product code NXC, 21 CFR 872.5470), cleared through the 510(k) process. SmileSet treatment is fully remote (mail-order, reviewed online).
Where the SmileSet 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.
- smileset.comhttps://smileset.com/
- smileset.comhttps://smileset.com/pages/aligners-to-straighten
- smileset.comhttps://smileset.com/pages/former-smiledirectclub-customers
- bbb.orghttps://www.bbb.org/us/tn/antioch/profile/dental-supplies/smileset-0573-37381840
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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 SmileSet
Every way to start, lowest price first.
SmileSet costs $1,395 (list $1,895); financing from about $87/mo via SmileSet, brand direct (at-home), across 1 tracked way to start.
Some outbound links on this site are referral links. If you sign up or buy through one, we may earn a commission at no extra cost to you. It never changes the price you pay or the underlying data. Partner status is one bounded, disclosed signal in how we order results: all else equal it can lift a partner above a comparable option, but it is capped so a clearly cheaper or better-reviewed option still ranks first, and every partner is labeled.
Prices are each brand's stated starting figure, not the total cost. They change often; each links to its source. Re-verified 2026-11-11. This is information, not dental or medical advice.
Clinical evidence & professional guidance
No registered study names SmileSet
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).