K Clear
K Clear is the clear-aligner brand of K Line Europe GmbH, an FDA-registered German manufacturer (Duesseldorf, founded 2014) that positions itself as Europe's largest OEM clear-aligner maker, with capacity for roughly 6 million aligners a year. It is a doctor-directed system sold on an OEM / white-label basis to dentists, orthodontists, DSOs and aligner brands rather than to patients directly, so a patient starts treatment through a treating clinician and often receives it under the practice's own label. The K Clear device received FDA 510(k) clearance in March 2022 (K220726, product code NXC), and the company markets a best-in-class 15.8% refinement-rate claim and a 3-to-5-day manufacturing turnaround (14 to 16 days to the clinic). K Line does not publish patient pricing: the fee is set entirely 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.
Not sold direct to consumers. K Clear is an OEM / white-label product obtained only through a treating dentist or orthodontist (in the US, distributed from a Florida center since 2023), frequently marketed to patients under the practice's own brand name. Sources
At a glance
Prices verified Nov 12, 2026K Clear (K Clear aligners, ClearX) 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 K Clear's own words: Crowding; Spacing and gaps; Bite correction (per the treating provider). Sources
A series of custom clear trays prescribed and fitted by a dentist or orthodontist after an in-office 3D scan, each worn 20 to 22 hrs/day and changed about every 1 to 2 weeks to move teeth incrementally. Trays are made from K Flex, K Line's proprietary multi-layered thermoplastic (a soft inner layer between firmer outer layers) designed for comfort, durability and predictable movement. Treatment plans are designed by K Line's in-house orthodontists and dentists rather than by AI software. 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 “K Clear” 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.
K Clear: Direct in-office supervision by a licensed dentist or orthodontist throughout treatment; K Line states its treatment plans are designed by its in-house orthodontists and dentists rather than by AI software Sources
Brand specs
Clear aligners are FDA Class II devices (product code NXC, 21 CFR 872.5470), cleared through the 510(k) process. K Clear treatment is in-office (doctor-directed, fitted through in-person visits).
Where the K Clear 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.
- dentalproductsreport.comhttps://www.dentalproductsreport.com/view/k-line-europe-s-oem-clear-aligners-now-available-in-the-us
- dentistrytoday.comhttps://www.dentistrytoday.com/europes-largest-oem-clear-aligner-manufacturer-is-now-in-the-usa/
- klinealigner.comhttps://www.klinealigner.com/premium-clear-aligner-manufacturing
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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 K Clear
Every way to start, lowest price first.
K Clear costs Provider-set (not published) via K Clear (K Line Europe), 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 K Clear
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 brands to compare
All 20 head-to-head comparisons with K Clear
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