Safety

The FDA safety record of every clear aligner brand

Name: Clear aligner FDA safety record
Creator: InvisibleBraces
License: https://www.usa.gov/government-works

Clear aligners are FDA Class II devices, and the FDA tracks their recalls and adverse-event reports. This is the record no brand shows you, pulled from openFDA with every figure linked to the FDA record behind it.

Read from the FDA Nov 13, 2026

2open recalls

18,652FDA reports (all brands)

14brands with reports

94brands tracked

2 FDA device recalls are open under the aligner product code: Byte (Class II, Z-0750-2025) and Clarity Aligners (Class II, Z-0743-2025). Across all clear aligners the FDA holds 18,652 MAUDE reports under product code NXC, most of them filed under Byte (15,439) and SmileDirectClub (1,602). 71 brands on sale have no report on file under their names, which partly reflects how new or small they are.

FDA device classClass II Product codeNXCAligner, Sequential Regulation21 CFR 872.5470 SpecialtyDental

Recalls

FDA device recalls

Every FDA device recall filed under the aligner product code NXC, with the brand, reason and affected products.

Byte Class II Ongoing

Recall Z-0750-2025

5,324,178devices

Recalling firm: Straight Smile, LLC (Byte)
Reason: Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
Affected product: BYTE Aligner System (All-Day and At-Night), a custom-made orthodontic appliance worn in series.
Initiated: Nov 4, 2024

Open the FDA recall record

Clarity Aligners Class II Ongoing

Recall Z-0743-2025

171orders

Recalling firm: 3M Company - Health Care Business (Clarity)
Reason: Attachments may not mate with the tooth as intended in the digital treatment design.
Affected product: 3M Clarity Precision Grip Attachments (dual-arch), used in Clarity Aligners orthodontic treatment.
Initiated: Nov 22, 2024

Open the FDA recall record

The full list is the openFDA query for every recall under product code NXC; a brand absent from it has no recall on file.

Adverse events

FDA adverse-event reports by brand

MAUDE reports filed with the FDA under the aligner product code, by the brand name they were filed under. Bigger and older brands accumulate more, and every count opens the openFDA query that returns it.

18,652 reports in total: 18,237 filed under the 14 tracked brands below with reports, and 415 under other or no brand names.

Glidewell Clear Aligners

Straight Teeth Direct

Other or no brand name

415

Reports are submitted by manufacturers, clinicians, and patients and are not verified by the FDA; a report is not proof the device caused harm, and a count is not a rate (it has no denominator of patients treated). The “other or no brand name” row is the total minus the tracked brands, so the rows add up to the total. Read it as a volume signal alongside price and treatment length, not a verdict.

Changes

How the FDA counts have moved

We read every count from the FDA every day and keep each one it has had. These are the counts that changed since the first one we recorded, with the dates of both readings.

Filed under	First recorded	Now	Change
Every aligner brand (product code NXC)	18,543 Sep 30, 2026	18,652 Nov 10, 2026	+109
Byte	15,405 Sep 30, 2026	15,439 Nov 10, 2026	+34
Invisalign	876 Sep 30, 2026	901 Nov 10, 2026	+25
SmileSet	10 Sep 30, 2026	34 Nov 10, 2026	+24
SureSmile	45 Sep 30, 2026	55 Nov 10, 2026	+10
Candid	70 Sep 30, 2026	71 Nov 10, 2026	+1
ClearCorrect	62 Sep 30, 2026	63 Nov 10, 2026	+1
Spark	36 Sep 30, 2026	37 Nov 10, 2026	+1

A rise is new reports filed with the FDA, which can describe events from any earlier time; a fall is the FDA correcting or merging reports. Neither is a rate. The FDA last updated this database on Nov 4, 2026.

What it means

What the reports are, and what the authorities advise

A count is a volume signal, not a verdict. Here is what those FDA reports actually describe, and where the major dental bodies stand on straightening teeth without an in-person exam.

Dental bodies caution against straightening teeth without an in-person exam

Caution

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 Orthodontistsas of Dec 1, 2023

Reported harms in the FDA device adverse-event database

Context

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

By brand

Brand-specific safety notices

FDA enforcement actions and continuity-of-care events tied to a specific brand, including an FDA Warning Letter to a brand still selling that carries no recall or adverse-event count.

Byte: FDA-driven suspension and Class II recall of the at-home system

Caution

Byte

In October 2024 Dentsply Sirona voluntarily suspended sales of the Byte Aligner System and impression kits in consultation with the FDA, and Byte / SDC Holdings initiated an ongoing Class II recall (initiated November 4, 2024) because the virtual-only clinical workflow may not be suitable for patients with certain contraindications. In January 2025 Dentsply confirmed the at-home systems would not return for new patients, and Byte's website now states that Byte has concluded its operations. Byte is no longer available to new patients.

FDA device recall and enforcement via openFDA; Dentsply Sironaas of Nov 4, 2024

SmileDirectClub: mid-treatment customers stranded by the 2023 shutdown

Context

SmileDirectClub

After filing Chapter 11 in September 2023, SmileDirectClub abruptly ceased all global operations on December 8, 2023 and then liquidated, leaving many customers mid-treatment without support, refunds, or the promised lifetime touch-up program, while some were still billed. The New York Attorney General later recovered $4.8 million for consumers wrongly charged after the shutdown. A continuity-of-care failure that is part of why the direct-to-consumer aligner market has contracted.

New York Attorney General; company filingsas of Dec 8, 2023

2USmiles: 2023 FDA Warning Letter over an uncleared treatment-planning change and misleading FDA claims (closed out in 2024)

Context

2USmiles

In June 2023 the FDA issued Vitang Technology LLC (which operates the 2USmiles / UniSmile clear-aligner system) a Warning Letter after an inspection: the company had switched the device's treatment-planning software from the FDA-cleared Orchestrate 3D to the non-cleared iRok OrthoRx 4.0 without submitting a new 510(k), its website carried misleading "FDA APPROVED" claims and the FDA logo, and the inspection also found quality-system violations. On July 23, 2024 the FDA issued a close-out letter stating that the company appears to have addressed the violations, while noting that future inspections will assess whether the corrections are adequate and sustained. 2USmiles remains a low-cost, fully remote (exam-free) brand selling to new patients.

U.S. Food & Drug Administration (Warning Letter 653455 and its July 2024 close-out letter)as of Jul 23, 2024

Clarity Aligners: open Class II recall of Clarity Precision Grip Attachments

Caution

Clarity Aligners

On November 22, 2024, 3M began a voluntary Class II recall (Z-0743-2025) of Clarity Precision Grip Attachments, which are used with Clarity Aligners, because a software nonconformance meant that attachments for the lower arch of specific dual-arch orders may not mate with the tooth as intended in the digital treatment design. The recall covers 171 orders distributed in the US, Canada, Australia and New Zealand, and practices were told not to use, and to dispose of, product from the affected case IDs. The FDA lists the recall as open. A Clarity patient with concerns about how their attachments fit should ask their orthodontist.

U.S. Food & Drug Administration, medical device recall database (recall Z-0743-2025)as of Nov 22, 2024

Graphy: three 2025 FDA reports relay one orthodontist's account of allergic-type reactions to Tera Harz Clear aligners

Context

Graphy

On June 16, 2025 the FDA received three voluntary reports, filed on behalf of one orthodontist, about Tera Harz Clear, the resin Graphy aligners are printed from (510(k) K240597). He said he told a Graphy representative at a conference that about 1 in 4 to 5 of his patients treated with it had reactions shortly after starting: difficulty breathing, lip and gum swelling and a sore throat, which they treated with over-the-counter antihistamines. These are one clinician's account as reported to the FDA, not an FDA finding, and the FDA lists no recall or warning letter for Graphy. Anyone who reacts to an aligner should stop wearing it and contact their dentist.

U.S. Food & Drug Administration, MAUDE adverse event reports (MW5171504 to MW5171506)as of Jun 16, 2025

Primary source: the openFDA device APIs (recalls, enforcement, and MAUDE adverse events). Every report count is read from the FDA every day, each with the query that returns it (last read Nov 13, 2026); the recall list is verified by hand and an automatic FDA recall feed also runs daily, so a recall it finds that is not yet in the verified list shows on that brand's page. See the FDA device-recall database.

Device-safety data is published by the FDA and can change. A brand with no reports on file is not guaranteed safe, and a suspended or discontinued brand may still affect people already in treatment. Confirm current device-safety with the FDA and a licensed dentist before starting.

InvisibleBraces is an informational data platform, not a dentist, an orthodontist, or a seller of aligners. Nothing here is dental or medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. At-home clear aligners are not right for every case, and moving teeth without an in-person exam carries real risk. Data is aggregated from public sources and each brand's own terms and can be incomplete or out of date. Always consult a licensed dentist or orthodontist and confirm current prices and terms with the provider.