NewSmile
Its store for another country: Canada.
A newer, discreet at-home brand (Canadian-owned) selling in the US, Canada, and UK. Day treatment $1,095 (list $1,795) and night aligners $1,195 (list $1,895), each paid one-time, with premium whitening included; retainers at the end of treatment cost extra. Typical treatment 4-6 months (day) or 8-10 (night). Full refund if you are not a candidate. 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: Black Friday Deal in United States, $800 off; Pre-Black Friday Sale in Canada, A limited-time price (seen on NewSmile's page Nov 12, 2026).
At a glance
Prices verified Nov 11, 2026NewSmile (NewSmile Day (Fast Track), NewSmile Night) 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
- Wear schedule
- All-day (~22 hrs) or night aligners (~10 hrs)
What it can treat
In NewSmile's own words: Mild-to-moderate crowding; Spacing and gaps; Minor relapse. Sources
Custom thin clear trays made from an at-home impression, reviewed and approved by a dentist or orthodontist remotely. Premium whitening is included, and a 3D preview is generated before you commit. 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 “NewSmile” 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.
NewSmile: Dentist or orthodontist-directed remotely; team reviews impressions and approves the plan Sources
Brand specs
- Refinements / touch-ups
- Not fully detailed publicly
- Clinical oversight
- Dentist or orthodontist-directed remotely; team reviews impressions and approves the plan
- HSA / FSA
- Eligible
- Headquarters
- Vancouver, British Columbia (Canadian-owned)
- Wear schedule
- All-day (~22 hrs) or night aligners (~10 hrs)
Clear aligners are FDA Class II devices (product code NXC, 21 CFR 872.5470), cleared through the 510(k) process. NewSmile treatment is fully remote (mail-order, reviewed online).
Where the NewSmile 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.
- newsmilelife.comhttps://www.newsmilelife.com/pages/clear-aligners
- newsmilelife.comhttps://www.newsmilelife.com/pages/faq
- health.usnews.comhttps://health.usnews.com/reviews/clear-braces/newsmile
- smileprep.comhttps://smileprep.com/ca/newsmile-canada-review/
Work at NewSmile? 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
Ways to start NewSmile
Every way to start, lowest price first.
NewSmile has 3 tracked ways to start; its plans are priced differently (some state no monthly figure), so each is shown with its own source below rather than ranked.
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 NewSmile
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).