Byte Aligners Lawsuit: Injuries, Refunds, and Shutdown

The Byte aligners lawsuit is actually a set of overlapping cases against Straight Smile LLC and its parent Dentsply Sirona, alleging the at-home clear aligners injured thousands of customers and were sold with dentist oversight that existed mostly on paper. A proposed consumer class action filed in March 2025 in federal court in Florida seeks refunds and damages for deceptive marketing and unsafe products, while attorneys are separately pursuing mass arbitration claims for injured customers nationwide. Dentsply Sirona suspended Byte sales in October 2024 and permanently shut the business down in early 2025.

What the Consumer Lawsuit Alleges

The case, Phillips v. Straight Smile LLC et al., No. 1:25-cv-21074, was filed March 7, 2025, in the U.S. District Court for the Southern District of Florida.¹ Plaintiff Paula Phillips accuses Byte and Dentsply Sirona of selling aligners that were neither safe nor effective and marketing them as “doctor-directed” when, according to the complaint, professional oversight was superficial.

The complaint also alleges Byte failed to report adverse patient incidents to regulators, kept selling aligners after internally identifying safety risks, and refused to issue refunds even after announcing the October 2024 sales suspension.¹

Six causes of action are pleaded:

Florida Deceptive and Unfair Trade Practices Act (FDUTPA)
Florida Misleading Advertising Statute (§ 817.41)
Breach of implied warranty of merchantability
Breach of implied warranty of fitness for a particular use
Breach of express warranty
Breach of contract

The proposed class covers Florida consumers who purchased a Byte aligner system and impression kit.² No specific class period appears in the complaint, though the alleged adverse events span October 2020 through October 2024.³

Injuries Reported by Byte Customers

The complaint and related filings describe a wide range of dental harm reported by users. Hundreds of adverse events were reported between October 2020 and October 2024, according to the complaint.³ Alleged injuries include:

Tooth fracture, chipping, and loosening
Pulp necrosis (dead teeth)
Bite misalignment and worsening of bite
Gum recession and periodontal disease
Bone loss
Jaw clicking and locked jaws
Facial swelling and mouth abscesses
Allergic reactions
Choking on improperly fitted aligners

One FDA adverse event report for a Byte Night Aligner describes a patient whose back teeth stopped touching after several months of use, causing difficulty chewing. The clinical evaluation found heavy contact on the front teeth and virtually no contact on the back teeth, with a risk of long-term trauma.⁴

The scale suggested by the parallel securities case is larger still. Investors allege Dentsply Sirona’s internal database tracked at least 6,894 serious patient injuries that were never reported to the FDA, roughly 97% of all injuries through December 2023.⁵ Some reportedly required surgical intervention, including bone grafts.⁶

How Byte Approved Patients for Treatment

The lawsuits’ central factual claim is that Byte’s “doctor-directed” screening was largely automated. According to the securities complaint, which relies on former-employee accounts, patients mailed in an impression kit and, if the mold looked workable, sales representatives moved them to a treatment plan drawn up by non-dentist “treatment planners” in Costa Rica. That plan then went to a remote U.S.-based dentist for sign-off.⁶

The software allowed a dentist to approve a case in about two minutes with four mouse clicks, the last applying an electronic signature. Dentists were paid per case. The complaint says this produced “super approvers” who signed off on around 30 cases a day at approval rates as high as 95%. If one or two dentists rejected a plan, the system automatically reassigned it to another, meaning a patient could be approved after being turned down twice.⁶

In August 2022, according to the complaint, Byte’s Head of Sales and Business Development instructed sales representatives to stop telling prospective patients they were contraindicated for treatment. After that meeting, reps stopped considering dental histories, and Byte’s conversion rate climbed roughly 20%.⁷ Once treatment began, the dentist network had no further involvement; customer service staff and dental assistants handled ongoing questions and were prohibited from referring patients to licensed dentists.⁶

When Judge Naomi Reice Buchwald ruled on the securities case in January 2026, she found investors had plausibly alleged the Byte system was “not ‘doctor-directed’ in any substantive sense, but rather designed to maximize the number of prescriptions approved without any meaningful input by dentists or orthodontists.”⁵

If You Were Injured or Want a Refund

Injured Byte customers have two main paths right now. Attorneys at the firm Milberg LLC are pursuing mass arbitration on behalf of Byte users nationwide who experienced injuries. Mass arbitration requires each consumer to submit their own claim rather than automatically joining a class.³ Florida purchasers may separately be covered by the proposed Phillips class action. At this stage, the class action does not require consumers to take any specific step to be part of it.²

Refunds have been a sore point independent of the injury claims. After the October 2024 sales suspension, customers reported through the Better Business Bureau being told refunds would come within 30 days but never receiving them. Others said Byte required them to sign “field safety” documents or visit an outside dentist at their own expense before it would address a refund request, which many said breached their original service agreements.⁸ Byte’s BBB profile lists 2,983 complaints over the prior three years, with service issues (1,149) and product issues (1,140) as the largest categories. The company is not BBB accredited.⁹ The Phillips complaint specifically alleges Byte failed to offer refunds despite its own admission that the products posed safety concerns.³

The Sales Suspension and Shutdown

Dentsply Sirona acquired Byte for $1.04 billion in an all-cash deal that closed December 31, 2020.¹⁰ On October 24, 2024, the company announced a voluntary suspension of all Byte aligner sales and marketing, halting the shipment and processing of new and recent orders.¹¹ Dentsply said the decision followed consultations with the FDA and a review of medical device reports showing its patient onboarding process may not have adequately screened out poor candidates.¹² The company also cited state regulations increasingly requiring in-person dental visits and X-rays, which undercut the at-home model.

Dentsply advised certain patients to stop treatment immediately and consult a dentist, specifically those with periodontal disease, severe open bite, dental implants, and adolescents with narrow jaws.³ On January 14, 2025, Dentsply announced it would not reinstate the at-home Byte system.¹³ By February 27, 2025, the company disclosed it was writing off Byte entirely and shutting the business down permanently.⁶

The Parallel Shareholder Case

A separate securities fraud class action, In re Dentsply Sirona, Inc. Securities Litigation, No. 24-cv-9083, is pending in the Southern District of New York on behalf of investors who bought Dentsply Sirona stock between May 6, 2021, and November 6, 2024.¹⁴ The investors allege Dentsply tracked injuries internally through a database called “Trackwise” but failed to report them to the FDA. The company had been submitting about 10 injury reports per month; the backlog began surfacing in retroactive filings starting February 2024, with 146 reports submitted in May 2024 alone.⁶ On January 27, 2026, Judge Buchwald largely denied Dentsply’s motion to dismiss, allowing most claims to proceed.¹⁵ This case is for shareholders, not aligner customers.

Current Status

The Byte at-home aligner business is permanently shut down. Both the consumer class action in Florida and the securities case in New York remain active, with no settlements proposed in either matter as of mid-2026.³ An amended securities complaint was filed May 9, 2025.¹⁶ Injured customers who want to pursue a claim now should contact firms handling Byte mass arbitration; Florida purchasers who paid for a Byte system and impression kit may also be covered by the pending class action without taking further action at this stage.²

1
ClassAction.org. Phillips v. Straight Smile LLC et al.
2
ClassAction.org. Byte Aligners Lawsuit Says Dental Products Are Ineffective, Dangerous
3
ClassAction.org. Byte Aligners Injuries Refund
4
FDA. MAUDE Adverse Event Report – Byte Night Aligner
5
Orthodontic Products Online. Federal Court Allows Dentsply Sirona Byte Aligner Lawsuit to Proceed
6
Skadden. In Re Dentsply Sirona Inc Securities Litigation
7
Bernstein Litowitz Berger & Grossmann LLP. Amended Consolidated Class Action Complaint – Dentsply Sirona
8
BBB. Byte BBB Complaints
9
BBB. Byte BBB Complaints
10
Dentsply Sirona Investor Relations. Dentsply Sirona Acquires Byte, Leading Direct-to-Consumer Doctor-Directed Aligner
11
Dentsply Sirona Investor Relations. Dentsply Sirona Provides Update on Byte Aligner Products
12
Reuters. Dentsply Sirona Voluntarily Suspends Sales of Its Teeth Aligners
13
Dentsply Sirona Investor Relations. Dentsply Sirona Announces Repositioning of Byte Within Aligner Portfolio
14
Bernstein Litowitz Berger & Grossmann LLP. Key West Police and Fire Pension Fund v. Dentsply Sirona Inc. et al.
15
Becker’s Dental Review. Dentsply Sirona Must Face Class Action Lawsuit on Byte Aligners, Court Rules
16
SEC. Dentsply Sirona SEC Filing