OrthoFX

Go to OrthoFX

OrthoFX is a doctor-directed clear aligner company (Fremont, California, founded 2017 by former Align Technology executives) whose aligners are prescribed and fitted only through licensed dentists and orthodontists, not sold direct to consumers. Its flagship AirFlex aligner (formerly NiTime, FDA cleared in 2023) is the first system cleared to straighten teeth with as little as 9 to 12 hours of daily wear using a patented HyperElastic polymer, with FXClear (tri-layer FXTetra material) and FXBright (whiter appearance) covering full-day treatment. Treatment is supervised in-office with visits about every 6 to 8 weeks plus FXOnTrack remote monitoring, and typically runs 6 to 18 months, with complex cases taking up to about 24. Because it is provider-fitted, the patient price is set by each practice, commonly about $2,000 to $5,500. Sources

AirFlex (formerly NiTime), FXClear (formerly Tetra), FXBright, FXRetainersOrthoFX, Inc. (Fremont, California), founded 2017 by former Align Technology executives Ren Menon (co-founder and CEO), Nichole Garcia, and Henry Chan (co-founder and CTO)

Sourced from each brand's published terms and primary FDA device records. Prices checked against their sources Nov 13, 2026, FDA records read Nov 10, 2026. How we verify. Not dental or medical advice.

At a glance

Prices verified Nov 13, 2026

OrthoFX (AirFlex (formerly NiTime), FXClear (formerly Tetra), FXBright, FXRetainers) 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: $2,000-5,500 provider-set
Wear schedule: Varies by product: AirFlex worn about 9 to 12 hrs/day (reduced-wear); FXClear and FXBright worn 20 to 22 hrs/day; trays typically changed about weekly per the treatment plan
Studies naming OrthoFX: 0of 134 registered clear aligner studies

What it treats

What it can treat

Crowding Spacing and gaps Overbite Underbite Crossbite

In OrthoFX's own words: Crowding; Spacing and gaps; Overbite; Underbite; Crossbite. 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 provider's supervision with FXOnTrack AI remote monitoring between visits. OrthoFX makes its aligners from proprietary polymers rather than off-the-shelf plastic: AirFlex uses a patented HyperElastic multi-copolymer engineered for sustained gentle force, FDA cleared to straighten teeth with only 9 to 12 hours of daily wear (about 50% less than leading brands) without adding treatment stages; FXClear uses the tri-layer FXTetra material (two tough outer layers that resist grinding plus an elastomeric inner layer for comfort) and is durable and stain-resistant at 20 to 22 hours of wear; FXBright brightens tooth appearance without gels. Each set moves teeth incrementally. 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. OrthoFX 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)3

A raw count of unverified FDA reports filed under “OrthoFX” 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

In-office every in-office brand

Your dentist or orthodontist fits and adjusts treatment through regular visits. Suits: complex bites and larger movements that need hands-on care.

OrthoFX: Doctor-directed: an in-person consultation and periodic office visits about every 6 to 8 weeks, with FXOnTrack AI remote monitoring and virtual check-ins between visits Sources

Specs

Brand specs

Start method: In-office consultation with a licensed dentist or orthodontist, including a 3D intraoral digital scan and diagnostic records; the provider designs the plan and fits the aligners (a provider 'Try It' sample kit is also offered before committing)
Material: Proprietary polymers by product: AirFlex uses a patented HyperElastic multi-copolymer engineered for sustained gentle force and reduced 9 to 12 hour daily wear; FXClear uses the tri-layer FXTetra polymer (two tough outer layers that resist bruxing plus an elastomeric inner layer for comfort), durable and stain-resistant; FXBright is a translucent aligner that brightens tooth appearance without whitening gels
Retainers: One complimentary set of FXRetainers included after treatment; replacement retainers offered via subscription (about $99 quarterly, $149 semi-annually, or $324 annually)
Whitening: FXBright aligners give teeth a whiter appearance without whitening gels; other whitening is at the provider's discretion
Refinements / touch-ups: Provider-managed additional aligners; refinement policy and cost are set by the treating provider. Broken aligners are replaced free, and a prorated refund is given for remaining aligners if treatment is discontinued
Guarantee: No manufacturer money-back satisfaction guarantee to consumers; free replacement of broken aligners and a prorated refund for unused aligners, with any results guarantee set by the individual provider
Clinical oversight: Doctor-directed: an in-person consultation and periodic office visits about every 6 to 8 weeks, with FXOnTrack AI remote monitoring and virtual check-ins between visits
Financing: FXPay patient financing: plans from about $99/month, 0% APR options, no or low down payment, up to $10,000, with instant approval, subject to credit approval (checking your plan does not affect your credit score; offered through the provider); a 98% approval rate is advertised
HSA / FSA: Generally HSA/FSA eligible as orthodontic treatment; depends on the provider and plan
Insurance: Often covered under orthodontic benefits (dental insurance with orthodontic coverage typically covers about $1,000 to $2,500); coverage varies by plan and provider
Availability: United States, through OrthoFX-authorized dentists and orthodontists (also operates in India via orthofx.in)
Headquarters: Fremont, California, USA
Wear schedule: Varies by product: AirFlex worn about 9 to 12 hrs/day (reduced-wear); FXClear and FXBright worn 20 to 22 hrs/day; trays typically changed about weekly per the treatment plan

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

Sources

Where the OrthoFX 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.

orthofx.comhttps://www.orthofx.com/
prnewswire.comhttps://www.prnewswire.com/news-releases/orthofx-features-a-full-line-of-clear-aligner-systems-using-the-newest-generation-of-proprietary-polymers-302406954.html
segoviaorthodonticslakewoodranch.comhttps://www.segoviaorthodonticslakewoodranch.com/what-is-orthofx-cost-and-is-it-worth-your-money/
smileprep.comhttps://smileprep.com/orthofx-review/

Work at OrthoFX? 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

Where to start

Ways to start OrthoFX

Every way to start, lowest price first.

OrthoFX costs $2,000 to $5,500 via OrthoFX, in-office (dentist / orthodontist), across 1 tracked way to start.

Provider, plan and what the price covers

Price

Get it

OOrthoFX In-office (dentist / orthodontist)
OrthoFX (provider-fitted) · Typical treatment about 6 to 18 months, with complex cases taking up to about 24 months per the cited guide. Provider-set total; varies by case complexity and practice. Example practice price $2,950 / from ~$85/mo (mabardidentalstudio.com/clear-aligners-with-orthofx); FXPay financing (orthofx.com/services/fxpay).
Provider-set: OrthoFX is sold only through dental practices, so each dentist or orthodontist sets the all-in fee, which often includes the aligners, office visits and sometimes a retainer at the end of treatment. A practice's own cost guide puts totals at roughly $2,000 to $3,000 for mild cases, $3,000 to $4,500 for moderate and $4,500 to $5,500+ for complex, and says dental insurance with orthodontic benefits typically covers $1,000 to $2,500. (reported)
$2,000 to $5,500
Visit

Prices are each brand's stated starting figure, not the total cost. They change often; each links to its source. Re-verified 2026-11-13. This is information, not dental or medical advice.

Evidence

Clinical evidence & professional guidance

No registered study names OrthoFX

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).

Questions

Common questions about OrthoFX

Is OrthoFX available to new patients?

Yes. OrthoFX 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 OrthoFX cost?

It costs $2,000 to $5,500 via OrthoFX, 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 OrthoFX treat?

OrthoFX treats crowding, spacing and gaps, overbite, underbite and crossbite. Complex bite problems, severe crowding, or cases needing significant tooth rotation usually need in-person care from an orthodontist.

Does insurance cover OrthoFX?

Insurance: Often covered under orthodontic benefits (dental insurance with orthodontic coverage typically covers about $1,000 to $2,500); 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 OrthoFX include retainers?

One complimentary set of FXRetainers included after treatment; replacement retainers offered via subscription (about $99 quarterly, $149 semi-annually, or $324 annually). Every brand's retainer terms, and what replacements cost when sold direct, are on the retainers page. Retainers by brand

Does OrthoFX offer a refund or guarantee?

Guarantee: No manufacturer money-back satisfaction guarantee to consumers; free replacement of broken aligners and a prorated refund for unused aligners, with any results guarantee set by the individual provider. Refinements (extra aligners if teeth do not move as planned): Provider-managed additional aligners; refinement policy and cost are set by the treating provider. Broken aligners are replaced free, and a prorated refund is given for remaining aligners if treatment is discontinued. Brand specs

What is the difference between OrthoFX and Invisalign?

OrthoFX is in-office (doctor-directed, fitted through in-person visits); Invisalign is in-office (doctor-directed, fitted through in-person visits). Price: OrthoFX $2,000-5,500 (provider-set), 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. OrthoFX vs Invisalign