Smartee
Smartee is a doctor-directed clear aligner system from Shanghai Smartee Denti-Technology, a Chinese digital-orthodontics company founded in 2004 that reports serving over 99,000 dental professionals across more than 57 countries and producing tens of millions of aligners. Treatment is prescription-only: a dentist or orthodontist takes an in-office 3D scan, submits the case through Smartee's digital workflow, and supervises aligners worn 20 to 22 hours a day and changed every 1 to 2 weeks. It handles mild to complex cases across children, teens and adults, including a dedicated GS line for mandibular-repositioning and skeletal cases. Because it is provider-fitted, the patient price is set by each practice (for example SGD 2,800 to SGD 9,800 in Singapore), and Smartee is not FDA-cleared or sold in the US; in October 2025 the Straumann Group took a single-digit equity stake to accelerate its international expansion. 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.
Doctor-directed and available to new patients today through Smartee-trained dentists and orthodontists in 57+ countries (including China, Spain, the UK and much of Asia). Smartee has no FDA 510(k) clearance and is not marketed in the United States, so US patients cannot start treatment with it. Sources
At a glance
Prices verified Nov 12, 2026Smartee (Smartee GE, alpha and GS clear aligners) is a clear aligner brand available to new patients that has no FDA device recall on file. Treatment is in-office (doctor-directed, fitted through in-person visits).
- Treatment length
- 6-18 monthstypical
- Supervision
- In-office
- FDA safety
- No recalls
- Starting price
What it can treat
In Smartee's own words: Crowding; Spacing and gaps; Deep bite and bite correction; Skeletal / mandibular-repositioning cases (GS). Sources
Custom clear aligner trays prescribed and fitted by a dentist or orthodontist after an in-office 3D scan, then worn at home under the clinician's supervision. Each set is worn 20 to 22 hours a day and changed about every 1 to 2 weeks, moving teeth incrementally, with clinic check-ins roughly every 6 to 10 weeks. Material: a proprietary multi-layer BPA-free thermoplastic aligner film (Singapore and UK providers describe it as a multi-layer 'A6/Mastertrack' film, trimmed to the gum line); Smartee also produces its own 'Smartee Platinum' dental thermoplastic sheets. 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 “Smartee” 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
Your dentist or orthodontist fits and adjusts treatment through regular visits. Suits: complex bites and larger movements that need hands-on care.
Smartee: Dentist or orthodontist directed, with in-clinic check-ins about every 6 to 10 weeks throughout treatment Sources
Brand specs
Clear aligners are FDA Class II devices (product code NXC, 21 CFR 872.5470), cleared through the 510(k) process. Smartee treatment is in-office (doctor-directed, fitted through in-person visits).
Where the Smartee 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.
- prnewswire.comhttps://www.prnewswire.com/news-releases/smartee-and-straumann-announce-strategic-partnerships-to-accelerate-innovation-in-orthodontics-302597875.html
- nofrillsdental.comhttps://www.nofrillsdental.com/smartee-aligners-in-singapore/
- kohedental.comhttps://kohedental.com/how-much-do-smartee-aligners-cost-in-singapore/
- smarteealigners.comhttps://www.smarteealigners.com/
Work at Smartee? 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 Smartee
Every way to start, lowest price first.
Smartee has 2 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 2026-11-12. This is information, not dental or medical advice.
Clinical evidence & professional guidance
1 registered study names Smartee.
Source: ClinicalTrials.gov API v2 · as of Nov 13, 2026
All clear aligner studies