Consumers who purchased Byte Aligner Systems claim they were misled about the safety and effectiveness of these dental products, according to a newly filed class action complaint that seeks damages and other remedies for alleged deceptive marketing practices. The complaint was filed on April 20, 2026, in the United States District Court for the Western District of North Carolina by Paula J. Phillips against Dentsply Sirona Inc.
The lawsuit centers on allegations that Dentsply Sirona Inc., a Delaware corporation with its principal place of business in Charlotte, North Carolina, engaged in deceptive acts under the Florida Deceptive and Unfair Trade Practices Act (FDUTPA). Plaintiff Paula J. Phillips brings the case individually and on behalf of all others similarly situated who purchased Byte Aligner Systems and Impression Kits in Florida.
According to the filing, Dentsply Sirona acquired Byte through an all-cash transaction valued at $1.04 billion on December 31, 2020. Following this acquisition, Dentsply Sirona promoted Byte as a “leading direct-to-consumer, doctor-directed clear aligner company” and claimed that dental professionals oversaw every treatment plan. These representations appeared in press releases, social media posts, securities filings, and prominently on Byte’s website alongside Dentsply’s name and logo.
The complaint outlines how Dentsply Sirona’s public statements vouched for the quality and professional oversight of Byte products. For example, a January 4, 2021 press release stated that combining with Byte would help “expand the market for orthodontic care by connecting additional patients with dental professionals.” Similar claims were made in Instagram posts directing consumers to purchase from Byte’s website.
Plaintiff alleges these statements were misleading because consumers did not receive direct dentist or orthodontist assessments before purchasing or using the products. Instead, customers used at-home impression kits mailed back to Byte for analysis before receiving their aligners. The lawsuit claims that unlike traditional aligners such as Invisalign or SureSmile—which require in-person assessments—Byte’s process lacked sufficient medical oversight.
The complaint further reports that from January 1, 2021 to October 31, 2024 there were over 2,500 incidents involving adverse events associated with Byte products reported to the U.S. Food and Drug Administration (FDA). These included allergic reactions, bite misalignment, bone loss, tooth fractures, gum recession, jaw issues, periodontal disease, severe pain and bleeding among other complications.
Despite having access to internal complaints data through its regulatory affairs department and being aware of these adverse effects via FDA reporting systems like Trackwise—a quality management system for FDA reporting—the plaintiff asserts that Dentsply Sirona continued promoting Byte as safe and effective.
On October 24-25, 2024—after thousands of adverse events had been reported—Dentsply Sirona announced it would suspend sales and marketing of Byte Aligner Systems pending a review of regulatory requirements. In a conference call with investors on October 25th CEO Simon Campeon admitted: “we have determined that our patient onboarding workflow may not provide adequate assurance that certain contraindicated patients do not enter treatment with Byte aligners.” Despite this admission regarding insufficient oversight by dental professionals in their model—and after years of promotion—the company maintained publicly that potential risk remained low.
Plaintiff Paula J. Phillips states she purchased an impression kit from Byte’s website after seeing advertising by Dentsply Sirona on April 18, 2024; she later bought aligners for $2,499 plus related items totaling $3,338.02 under an installment contract. After using the product she experienced pain and bleeding severe enough to stop use but was denied a refund by Byte’s policies even after learning sales had ceased months earlier.
The lawsuit seeks certification as a class action representing all Florida purchasers of Byte Aligner Systems and Impression Kits; actual damages; declaratory relief finding Dentsply Sirona’s conduct violated FDUTPA; attorneys’ fees; costs; interest; and any other relief deemed appropriate by the court.
Attorneys representing plaintiff include Matthew E. Lee (Lee Segui PLLC), Jordan A. Dresnick (Law Offices of Jordan A. Dresnick), Stuart Z. Grossman (Grossman Roth Yaffa Cohen P.A.), Manuel A. Arteaga-Gomez (Grossman Roth Yaffa Cohen P.A.), Ryan J. Yaffa (Grossman Roth Yaffa Cohen P.A.), with pro hac vice applications pending where noted. The case is identified as Civil Action No.: 3:26-cv-00304-MOC-WCM.
Source: 326cv00304_Phillips_v_Dentsply_Sirona_Inc_Complaint_Western_District_North_Carolina.pdf
