i-liner
i-liner is a Made-in-Italy clear-aligner system from Sia Orthodontic Manufacturer S.r.l., an orthodontic manufacturer established in 2000 and based in Rocca d'Evandro (Caserta), Italy. It is a professional (B2B), prescription-only product sold and delivered only through trained dentists and orthodontists, not direct-to-consumer; patients reach it by finding a provider in i-liner's network. Aligners are made from FLEXY, a proprietary multilayer thermoplastic (about 92% light transmission, stain-resistant, continuous force release), planned digitally on i-liner's Digital HUB and delivered with a SmileBox and a final retention aligner per arch. No patient price is published: the treating dentist sets and quotes the fee, and i-liner does not publish a fixed treatment length, though clear-aligner treatment generally runs about 6 to 18 months depending on case complexity. Sia Orthodontic states it markets its products in several countries worldwide. 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.
i-liner is a professional, doctor-directed brand available only through trained dentists and orthodontists (not sold direct-to-consumer); it is Made in Italy by Sia Orthodontic Manufacturer S.r.l. (established 2000), which states it markets its orthodontic products in several countries worldwide. Verified on https://i-liner.it/en/our-company/ and https://i-liner.it/en/patient-homepage/ Sources
At a glance
Prices verified Nov 12, 2026i-liner (i-liner) 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
What it can treat
In i-liner's own words: Mild-to-moderate crowding; Spacing and gaps; Aesthetic alignment for adults and teenagers; Complex cases via mixed therapy (aligners combined with fixed brackets). Sources
A series of custom clear trays thermoformed from FLEXY, Sia Orthodontic's proprietary multilayer thermoplastic sheet, that move teeth incrementally. FLEXY is engineered for high transparency (about 92% light transmission), high resistance to staining, and a continuous, constant release of forces over time for predictable movements. Setups are produced on high-precision industrial 3D printers with post-polymerization, ultrasound washing, CAD/CAM trim-line design driving CNC milling, industrial tumbling for smooth polished edges, and laser marking of the positioning arch and aligner number. The whole plan is designed and supervised digitally by the treating dentist through i-liner's Digital HUB, so it is doctor-directed rather than self-directed. 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 “i-liner” 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.
i-liner: Dentist-led and in-office: every case is designed, prescribed and supervised by a trained dentist or orthodontist via the Digital HUB; not available direct-to-consumer. Sources
Brand specs
Clear aligners are FDA Class II devices (product code NXC, 21 CFR 872.5470), cleared through the 510(k) process. i-liner treatment is in-office (doctor-directed, fitted through in-person visits).
Where the i-liner 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.
- i-liner.ithttps://i-liner.it/en/
- i-liner.ithttps://i-liner.it/en/the-product/
- i-liner.ithttps://i-liner.it/en/our-company/
- i-liner.ithttps://i-liner.it/en/patient-homepage/
Work at i-liner? Correct this listing or set up a referral link
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 i-liner
Every way to start, lowest price first.
i-liner costs Provider-set via i-liner (Sia Orthodontic Manufacturer), 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 i-liner
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).