Spark

Spark Clear Aligners is a doctor-only clear aligner system from Ormco (part of Envista) made with its patented TruGEN and TruGEN XR material, positioned as a more transparent, stain-resistant alternative to Invisalign. It is dispensed exclusively in-office by dentists and orthodontists, who diagnose, plan, and supervise treatment for cases ranging from mild to complex. Because it is provider-fitted rather than direct-to-consumer, the patient price is set by each practice, typically about $3,500 to $8,000. 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.

Spark (Spark 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
6-18 monthstypical
Supervision
In-office
FDA safety
No recalls
Starting price
Wear schedule
20 to 22 hrs/day, trays changed roughly every 7 to 14 days per the treatment plan
Studies naming Spark
2of 134 registered clear aligner studies
What it treats

What it can treat

In Spark's own words: Crowding; Spacing and gaps; Overbite; Underbite. Sources

Custom clear aligner trays prescribed and fitted by a dentist or orthodontist after an in-office 3D scan. Each set is worn 20 to 22 hrs/day, trays changed roughly every 7 to 14 days per the treatment plan, moving teeth incrementally. Material: TruGEN and TruGEN XR (Ormco), a 0.75mm polymer free of BPA, latex, phthalates, and mercury; marketed as clearer, more stain-resistant, and better contoured to the tooth than the leading brand. 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. Spark 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)37

A raw count of unverified FDA reports filed under “Spark” 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. Up from 36 on Sep 30, 2026, the first count we recorded.

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.

Spark: Doctor-directed with in-person progress visits about every 4 to 8 weeks (some providers add remote monitoring between visits) Sources

Specs

Brand specs

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

Sources

Where the Spark 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. newmouth.comhttps://www.newmouth.com/spark/
  2. ormco.comhttps://ormco.com/en-us/spark/trugen-material
  3. ormco.comhttps://ormco.com/en-us/spark/treatment-options
  4. ormco.comhttps://ormco.com/en-us/spark-clear-aligners
  5. sparkaligners.comhttps://sparkaligners.com/en-au/faq
  6. web.archive.orghttps://web.archive.org/web/20260711143612id_/https://sparkaligners.com/en-za
  7. web.archive.orghttps://web.archive.org/web/20260608225520id_/https://sparkaligners.com/es-mx

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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

2 registered studies name Spark.

Related

Related brands to compare

All 22 head-to-head comparisons with Spark
Questions

Common questions about Spark

Is Spark available to new patients?
Yes. Spark 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 Spark cost?
It costs $3,500 to $8,000 via Spark, 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 Spark treat?
Spark treats crowding, spacing and gaps, overbite and underbite. Complex bite problems, severe crowding, or cases needing significant tooth rotation usually need in-person care from an orthodontist.
Does insurance cover Spark?
Insurance: Often covered under orthodontic benefits, though some dental plans treat adult aligners as cosmetic; coverage varies by plan and provider. HSA and FSA: Generally HSA/FSA eligible as orthodontic treatment (confirmed accepted per NewMouth review); 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 Spark include retainers?
Spark Retainers (launched 2025) available through the provider; retainers required after treatment to prevent relapse (provider-set cost). Every brand's retainer terms, and what replacements cost when sold direct, are on the retainers page. Retainers by brand
Does Spark offer a refund or guarantee?
Guarantee: No manufacturer-level consumer guarantee; any satisfaction or results guarantee is set by the individual provider. Refinements (extra aligners if teeth do not move as planned): Provider-managed additional trays; TruGEN and TruGEN XR are available for both primary and refinement stages. Refinement policy and cost are set by the treating provider (not published as a fixed manufacturer allowance). Brand specs
What is the difference between Spark and Invisalign?
Spark is in-office (doctor-directed, fitted through in-person visits); Invisalign is in-office (doctor-directed, fitted through in-person visits). Price: Spark $3,500-8,000 (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. Spark vs Invisalign