Orthocaps

Orthocaps is a doctor-directed, prescription-only clear-aligner system made by Ortho Caps GmbH in Hamm, Germany (founded 2006 by orthodontist Dr. Wajeeh Khan). It is not sold direct to consumers: patients are treated only through a certified orthocaps orthodontist or dentist, who takes the impressions or scan, bite registration and X-rays and oversees the plan. Its signature TwinAligner design splits each stage into a soft daytime aligner and a thicker nighttime aligner. It received FDA 510(k) clearance (K180241) in 2018, is distributed in about 35 countries (in the US and Canada exclusively through Rocky Mountain Orthodontics), and total treatment typically costs about EUR 1,500 to EUR 8,000, set individually by the treating practice. 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.

Orthocaps (orthocaps TwinAligner (PRO, NOCTIS, KIDS, TEN, TEN+TEN, HAT)) 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
Standard systems (PRO, TEN, HAT, TEN+TEN) worn at least ~22 hrs/day, each set changed every 2 to 3 weeks; the NOCTIS system is night-only (worn overnight on weekdays, plus daytime at weekends)
Studies naming Orthocaps
0of 134 registered clear aligner studies
What it treats

What it can treat

In Orthocaps's own words: Crowding; Deep bite; Open bite; Overbite; Class II occlusion; Contracted / narrow arches. Sources

The orthocaps TwinAligner system uses two separate custom trays per stage: a soft, thin DAYcap for comfort and aesthetics and a thicker NIGHTcap for higher, customized force delivery. Each tray is a 2-component thermoplastic with a soft inner layer for grip and a firmer outer layer for force application, thermoformed in Germany. Worn about 22 hours a day and changed every 2 to 3 weeks (ten numbered sets per phase), the sequence moves teeth incrementally under an orthodontist's control, planned from a 3D iSetup simulation and reviewed with a Treatment Evaluation Report (TER) at the end of each phase. 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. Orthocaps 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 “Orthocaps” 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.

Orthocaps: Doctor-directed: treatment is prescribed, fitted and monitored by a certified orthocaps orthodontist or dentist; the case is planned from an iSetup 3D simulation and each phase closes with a Treatment Evaluation Report (TER). Not available direct-to-consumer. Sources

Specs

Brand specs

Whitening
Not published
Guarantee
Not published

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

Sources

Where the Orthocaps 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. orthocaps.comhttps://orthocaps.com/faq/
  2. orthocaps.comhttps://orthocaps.com/treatment-process/
  3. prnewswire.comhttps://www.prnewswire.com/news-releases/orthocaps-aligners-receive-fda-clearance-300736340.html

Work at Orthocaps? 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 Orthocaps

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 25 head-to-head comparisons with Orthocaps
Questions

Common questions about Orthocaps

Is Orthocaps available to new patients?
Yes. Orthocaps 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 Orthocaps cost?
It costs About EUR 1,500 to EUR 8,000 total (provider-set) via Orthocaps, 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 Orthocaps treat?
Orthocaps treats crowding, deep bite, open bite, overbite, class ii occlusion and contracted / narrow arches. Complex bite problems, severe crowding, or cases needing significant tooth rotation usually need in-person care from an orthodontist.
Does insurance cover Orthocaps?
Insurance: Not published (depends on the patient's plan and the treating practice). HSA and FSA: Not published (handled by the treating US practice where applicable). Both from the brand's own terms and the reviews cited for it; check with your own plan before you buy. Brand specs
Does Orthocaps include retainers?
Not published (post-treatment retention is arranged by the treating practice). Every brand's retainer terms, and what replacements cost when sold direct, are on the retainers page. Retainers by brand
Does Orthocaps offer a refund or guarantee?
Guarantee: Not published. Refinements (extra aligners if teeth do not move as planned): Not published (additional aligners and plan revisions are handled per case by the treating orthodontist; the maker issues a 3D Treatment Evaluation Report at the end of each phase). Brand specs
What is the difference between Orthocaps and Invisalign?
Orthocaps is in-office (doctor-directed, fitted through in-person visits); Invisalign is in-office (doctor-directed, fitted through in-person visits). Price: Orthocaps ~€1,500-8,000 (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. Orthocaps vs Invisalign