uLab
uSmile is the clear aligner brand of uLab Systems, a doctor-directed, in-office platform sold to orthodontists and dentists rather than to consumers. The treating doctor plans each case in uLab's uDesign software and either 3D-prints the aligners in the office the same day or orders uSmile aligners from uLab's Memphis facility, using the proprietary Reva material. Because it is a professional B2B product, the patient's fee is set by the practice and uLab publishes no dollar pricing: since June 2023 its pricing to practices has combined case bundles and a la carte options with a per-patient total case backstop. 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, 2026uLab (uSmile 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
- Not published
- Supervision
- In-office
- FDA safety
- No recalls
- Starting price
What it can treat
In uLab's own words: Crowding; Spacing and gaps; Complex / comprehensive cases (per provider). Sources
Custom clear aligner trays prescribed and fitted by an orthodontist or dentist after an in-office 3D scan. The doctor plans the case in uLab's uDesign AI software (movement plans in as little as about 10 minutes) and then either 3D-prints or thermoforms the aligners in-office the same day or orders uSmile aligners from uLab's US plant in Memphis. Each set is worn 20 to 22 hrs/day and changed about weekly to move teeth incrementally. Material: Reva thermoforming material (uLab), marketed as 17% thinner per aligner than leading brands, BPA- and phthalate-free, with an anti-glare satin finish and superior force retention. 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 “uLab” 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. 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.
uLab: Doctor-directed: prescribed, fitted, and monitored in-office by the treating orthodontist or dentist through routine in-person visits Sources
Brand specs
Clear aligners are FDA Class II devices (product code NXC, 21 CFR 872.5470), cleared through the 510(k) process. uLab treatment is in-office (doctor-directed, fitted through in-person visits).
Where the uLab 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.
- ulabsystems.comhttps://www.ulabsystems.com/usmile/
- prnewswire.comhttps://www.prnewswire.com/apac/news-releases/ulab-enables-direct-to-patient-shipments-for-usmile-retainers-301999114.html
- ulabsystems.comhttps://www.ulabsystems.com/ulab-announces-innovative-industry-first-pricing-structure-optimizing-orthodontic-costs-and-flexibility/
Work at uLab? 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 uLab
Every way to start, lowest price first.
uLab costs Provider-set (not published) via uLab Systems (uSmile), in-office (dentist / orthodontist), 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 uLab
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).
Related brands to compare
All 19 head-to-head comparisons with uLab
- uLab vs Alineadent
- uLab vs Angel Aligner
- uLab vs Clarity Aligners
- uLab vs ClearCorrect
- uLab vs ClearPath
- uLab vs Dandy Clear Aligners
- uLab vs Glidewell Clear Aligners
- uLab vs Graphy
- uLab vs Invisalign
- uLab vs K Clear
- uLab vs Motto
- uLab vs Orthocaps
- uLab vs OrthoFX
- uLab vs OrthoSnap
- uLab vs Six Month Smiles
- uLab vs Smile Academy
- uLab vs Smilers
- uLab vs Spark
- uLab vs SureSmile