F22 Aligner

F22 Aligner is a doctor-directed invisible aligner system made by Sweden & Martina in Padua, Italy, launched in 2015 and developed with the University of Ferrara School of Orthodontics. It is prescription-only and dispensed exclusively through dentists and orthodontists (the brand website is gated to dental professionals), with each case planned manually to a tenth of a millimetre and made from the brand's EvoFlex multi-layer material. Aligners are worn about 22 hours a day and changed every two weeks, with treatment typically lasting 12 to 18 months (about 3 to 6 months for mild cases). Because it is provider-fitted, F22 publishes no consumer price; one F22 reseller lists IDR 36,000,000 (about USD 2,000). 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.

F22 Aligner (F22 Aligner (EvoFlex)) 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
12-18 monthstypical
Supervision
In-office
FDA safety
No recalls
Starting price
Wear schedule
About 22 hrs/day, each aligner worn about 14 days
Studies naming F22 Aligner
0of 134 registered clear aligner studies
What it treats

What it can treat

In F22 Aligner's own words: Crowding; Spacing and gaps; Deep bite; Open bite; Crossbite; Underbite. Sources

Custom clear aligner trays prescribed and fitted by a dentist or orthodontist after in-office impressions or a 3D scan. Each aligner is worn about 22 hours a day and changed roughly every 14 days, moving teeth incrementally, and F22 also supports a hybrid approach in which small segments of fixed lingual orthodontics are covered by the aligner. Material: EvoFlex, a stratified multi-layer polymer with a highly elastic inner core between two rigid outer layers, marketed as delivering a gentler but constant force, with about 300% higher tear and tensile strength than the average aligner material, up to 17% more transparency, and stain resistance. Unlike software-programmed systems, F22 movements are planned manually to a tenth of a millimetre by a specialised team at the F22 Centre in Padua. 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. F22 Aligner 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)None on file

A raw count of unverified FDA reports filed under “F22 Aligner” 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.

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.

F22 Aligner: In-office: prescription-only, fitted and monitored by a treating dentist or orthodontist. Each case is planned manually to a tenth of a millimetre by the F22 team at the F22 Centre in Padua, and clinicians are supported by a tutor orthodontist from the University of Ferrara School of Orthodontics. Sources

Specs

Brand specs

Clear aligners are FDA Class II devices (product code NXC, 21 CFR 872.5470), cleared through the 510(k) process. F22 Aligner treatment is in-office (doctor-directed, fitted through in-person visits).

Sources

Where the F22 Aligner 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. f22aligner.comhttps://www.f22aligner.com/en/dentist-area-products/f22-aligner/
  2. dottordentista.comhttps://dottordentista.com/f22-aligner/
  3. pmc.ncbi.nlm.nih.govhttps://pmc.ncbi.nlm.nih.gov/articles/PMC5682257/

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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 F22 Aligner

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 10 head-to-head comparisons with F22 Aligner
Questions

Common questions about F22 Aligner

Is F22 Aligner available to new patients?
Yes. F22 Aligner 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 F22 Aligner cost?
It costs Provider-set (no published consumer price) via F22 Aligner, 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 F22 Aligner treat?
F22 Aligner treats crowding, spacing and gaps, deep bite, open bite, crossbite and underbite. Complex bite problems, severe crowding, or cases needing significant tooth rotation usually need in-person care from an orthodontist.
Does insurance cover F22 Aligner?
Insurance: Not published (varies by country and provider). HSA and FSA: Not applicable (Italy/Europe-based; no US direct-to-consumer channel). Both from the brand's own terms and the reviews cited for it; check with your own plan before you buy. Brand specs
Does F22 Aligner include retainers?
Not published. Every brand's retainer terms, and what replacements cost when sold direct, are on the retainers page. Retainers by brand
Does F22 Aligner offer a refund or guarantee?
Guarantee: Not published. Refinements (extra aligners if teeth do not move as planned): Not published (arranged through the treating provider). Brand specs
What is the difference between F22 Aligner and Invisalign?
F22 Aligner is in-office (doctor-directed, fitted through in-person visits); Invisalign is in-office (doctor-directed, fitted through in-person visits). Price: F22 Aligner 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. F22 Aligner vs Invisalign