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.

uLab (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
Wear schedule
20 to 22 hrs/day, trays typically changed about weekly (provider-directed)
Studies naming uLab
0of 134 registered clear aligner studies
What it treats

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

Safety & recalls

This brand's FDA device record under the aligner product code NXC: recalls and MAUDE adverse-event reports, verified Nov 10, 2026.

No FDA device recall on file. uLab does not appear in the FDA's list of every recall under product code NXC, checked Nov 10, 2026. The recalls that are on file are on the safety board.
FDA adverse-event reports (MAUDE)20

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.

Oversight

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

Specs

Brand specs

Whitening
Not published

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).

Sources

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.

  1. ulabsystems.comhttps://www.ulabsystems.com/usmile/
  2. prnewswire.comhttps://www.prnewswire.com/apac/news-releases/ulab-enables-direct-to-patient-shipments-for-usmile-retainers-301999114.html
  3. 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

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

Evidence

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

Related brands to compare

All 19 head-to-head comparisons with uLab
Questions

Common questions about uLab

Is uLab available to new patients?
Yes. uLab is a clear aligner brand currently available to new patients, with no FDA device recall on file under the aligner product code. Treatment is in-office (doctor-directed, fitted through in-person visits). Source
How much does uLab cost?
It costs Provider-set (not published) via uLab Systems (uSmile), in-office (dentist / orthodontist). Prices depend on the plan (all-day vs night-only, single vs dual arch) and change often, and financing can spread it into monthly payments. See it below. Source
What can uLab treat?
uLab treats crowding, spacing and gaps and complex / comprehensive cases (per provider). Complex bite problems, severe crowding, or cases needing significant tooth rotation usually need in-person care from an orthodontist.
Does insurance cover uLab?
Insurance: Often covered under orthodontic benefits; coverage varies by plan and provider. HSA and FSA: Generally HSA/FSA eligible as orthodontic treatment; depends on the provider and plan. Both from the brand's own terms and the reviews cited for it; check with your own plan before you buy. Brand specs
Does uLab include retainers?
uSmile retainers available through the provider; after an initial in-office fit, replacement retainers can ship direct to the patient (uDesign 7.3 or later), with custom office-branded cases. Every brand's retainer terms, and what replacements cost when sold direct, are on the retainers page. Retainers by brand
Does uLab offer a refund or guarantee?
Guarantee: Not published (patient-facing guarantee is set by the individual practice; uLab's assurance is the doctor-facing per-patient total case backstop). Refinements (extra aligners if teeth do not move as planned): Doctor-facing: since June 2023 uLab's pricing sets a per-patient total case backstop that the practice will not exceed, so aligners beyond it (including refinements) add no lab cost; any patient-facing refinement policy is set by the treating practice. Brand specs
What is the difference between uLab and Invisalign?
uLab is in-office (doctor-directed, fitted through in-person visits); Invisalign is in-office (doctor-directed, fitted through in-person visits). Price: uLab a fee each provider sets, Invisalign $1,800-8,000 (provider-set). Treatment length, what each treats and both FDA safety records are side by side on the comparison page. uLab vs Invisalign