Invisalign

Invisalign is the market-leading clear aligner system from Align Technology, cleared by the FDA in 1998 and now used in more than 100 countries by trained dentists and orthodontists. Treatment starts with an in-office iTero 3D scan, and custom SmartTrack aligners are worn 20 to 22 hours a day and changed about weekly under a provider's supervision. It treats the widest range of cases, from mild crowding to complex bite correction, at a provider-set price typically between $1,800 (minor Express cases) and $8,000. 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.

Invisalign (Invisalign 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
12-18 monthstypical
Supervision
In-office
FDA safety
No recalls
Starting price
Wear schedule
20 to 22 hrs/day, trays typically changed about weekly
Studies naming Invisalign
17of 134 registered clear aligner studies
What it treats

What it can treat

In Invisalign's own words: Crowding; Spacing and gaps; Overbite; Underbite. Sources

Custom clear aligner trays prescribed and fitted by a dentist or orthodontist after an in-office 3D scan. Each set is worn 20 to 22 hrs/day, trays typically changed about weekly, moving teeth incrementally. Material: SmartTrack (Align): a highly elastic multilayer thermoplastic developed after testing 260+ polymers, delivering gentler, more constant force. 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. Invisalign 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)901

A raw count of unverified FDA reports filed under “Invisalign” 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. Up from 876 on Sep 30, 2026, the first count we recorded.

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.

Invisalign: Dentist or orthodontist directed, with in-person checkups throughout treatment Sources

Specs

Brand specs

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

Sources

Where the Invisalign 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. realdentalcosts.comhttps://realdentalcosts.com/en/invisalign/
  2. dentalroundup.comhttps://www.dentalroundup.com/guides/invisalign-cost/
  3. myglowupdentistry.comhttps://myglowupdentistry.com/invisalign-cost-with-and-without-insurance/
  4. investor.aligntech.comhttps://investor.aligntech.com/news-releases/news-release-details/align-technology-introduces-next-generation-invisalignr-aligner
  5. invisalign.com.auhttps://www.invisalign.com.au/choose-your-geography

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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

Where to start

Ways to start Invisalign

Every way to start, lowest price first.

Invisalign has 7 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.

What Invisalign costs in full, by type of case, in every state, with insurance, an HSA or FSA, and the extras a quote can leave out: Invisalign cost.

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.

Evidence

Clinical evidence & professional guidance

17 registered studies name Invisalign, 2 with reported results (shown first).

Related

Related brands to compare

All 81 head-to-head comparisons with Invisalign
Questions

Common questions about Invisalign

Is Invisalign available to new patients?
Yes. Invisalign 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 Invisalign cost?
Invisalign is offered in 7 tracked ways, priced differently (some plans state no monthly figure), so each is listed with its own source below. Prices change often, and financing can spread the cost into monthly payments.
What can Invisalign treat?
Invisalign treats crowding, spacing and gaps, overbite and underbite. Complex bite problems, severe crowding, or cases needing significant tooth rotation usually need in-person care from an orthodontist.
Does insurance cover Invisalign?
Insurance: Often partially covered by dental or orthodontic benefits, with many plans applying a lifetime orthodontic maximum (commonly up to about $3,000). HSA and FSA: Eligible for HSA and FSA reimbursement as orthodontic care. Both from the brand's own terms and the reviews cited for it; check with your own plan before you buy. Brand specs
Does Invisalign include retainers?
Vivera retainers, custom-made and sold in sets of four, commonly $400 to $1,200; nightly wear recommended long-term to prevent relapse. Every brand's retainer terms, and what replacements cost when sold direct, are on the retainers page. Retainers by brand
Does Invisalign offer a refund or guarantee?
Guarantee: Not published (no manufacturer money-back guarantee; any guarantee is provider-dependent). Refinements (extra aligners if teeth do not move as planned): Additional aligner sets (refinements) to fine-tune results, typically included within comprehensive plans; exact allowance is provider-dependent. Brand specs