Alineadent
Alineadent is a "made in Spain" invisible-orthodontics brand and a division of the Malaga laboratory Ortoplus (founded 1992 by Jesus Garcia Urbano), developed on research from the University of Malaga. It is doctor-directed and sold only through certified dental clinics, not direct-to-consumer: a certified dentist takes a 3D scan, Ortoplus returns the treatment plan and manufactures the trays (up to about 2,000 aligners per day), and the dentist delivers and supervises them. Patients wear each transparent polycarbonate tray at least 22 hours a day, changing sets every two weeks, with treatment typically lasting 9-12 months (6-12 for mild cases, up to 18-24 for severe). The patient price is set by the treating clinic and is reported at roughly 3,500-4,000 euros. Ortoplus exports Alineadent to more than 50 countries (about 80 percent of output), with the US, Germany and Belgium among its key markets. 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.
Alineadent is a professional (B2B) brand sold only through Alineadent-certified dental clinics, not direct to consumers; the patient price is set by the treating clinic. Sources
At a glance
Prices verified Nov 12, 2026Alineadent (Alineadent 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
- 9-12 monthstypical
- Supervision
- In-office
- FDA safety
- No recalls
- Starting price
What it can treat
In Alineadent's own words: Crowding; Spacing and gaps; Overbite; Crossbite. Sources
Custom clear aligner trays are made by the Ortoplus laboratory in Malaga from a 3D digital scan taken by a certified dentist, then worn to move teeth incrementally, with tray thickness stepped up through the plan (thinner at the start for easier adaptation). Each set is worn at least 22 hours a day and changed about every two weeks. Material: transparent polycarbonate plastic, custom-fabricated per patient. Treatment is planned in the Alineadent LineDock software (developed with University of Malaga specialists) and overseen by the treating orthodontist. Sources
Safety & recalls
This brand's FDA device record under the aligner product code NXC: recalls and MAUDE adverse-event reports, verified Nov 10, 2026.
A raw count of unverified FDA reports filed under “Alineadent” 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.
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.
Alineadent: In-office / dentist-led: a certified dentist or orthodontist diagnoses, plans (via the Alineadent LineDock platform), delivers and monitors treatment in person, with fewer visits than fixed braces Sources
Brand specs
- Retainers
- Not published
- Whitening
- Not published
- Refinements / touch-ups
- Set per treatment plan by the treating dentist; Ortoplus returns treatment plans in about 24-48 hours and fabricates trays in about 48 hours after approval
- Guarantee
- Not published
- Insurance
- Not published
Clear aligners are FDA Class II devices (product code NXC, 21 CFR 872.5470), cleared through the 510(k) process. Alineadent treatment is in-office (doctor-directed, fitted through in-person visits).
Where the Alineadent 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.
- alineadent.comhttps://www.alineadent.com/que-es-la-ortodoncia-invisible/
- dentaly.orghttps://www.dentaly.org/es/ortodoncia/invisible/alineadent/
- vidaeconomica.comhttps://www.vidaeconomica.com/2019/06/ortoplus-la-presencia-en-europa-de-un-grupo-dental-malagueno/
- vidaeconomica.comhttps://www.vidaeconomica.com/2026/04/ortoplus-malaga-tecnologia-3d-ortodoncia-expansion/
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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
Ways to start Alineadent
Every way to start, lowest price first.
Alineadent costs 3,500-4,000 euros (clinic-set) via Alineadent-certified dental clinics (Ortoplus), in-office (dentist / orthodontist), across 1 tracked way to start.
Prices are each brand's stated starting figure, not the total cost. They change often; each links to its source. Re-verified 2026-11-12. This is information, not dental or medical advice.
Clinical evidence & professional guidance
No registered study names Alineadent
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).
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