The AAO offered guidance to patients one year ago following the SmileDirectClub bankruptcy and closure announcement.

 This month a New York State Attorney General’s office press release reported that, “New York Attorney General Letitia James today recovered $4.8 million for more than 28,000 consumers, including 2,265 New Yorkers, who were improperly charged by the telehealth company SmileDirectClub.”

The press release provided more background on the situation:  

“In September 2023, SmileDirectClub filed for Chapter 11 bankruptcy, and in December 2023, while tens of thousands of consumers were still receiving aligner treatment, the company announced that it was shutting down its platform, canceling outstanding aligner orders, and ceasing all other business operations effective immediately. Despite SmileDirectClub’s permanent closing, the company’s website continued to misleadingly advise consumers, including those who had not completed their aligner treatment, that they must make any remaining monthly installment payments in full.” 

AAO Vice President of Advocacy Nathan Mick said, “While we applaud the consumer protection efforts by leaders like New York Attorney General James, the threat posed to patient health and safety from mail-order orthodontic treatment models has not gone away, even with the closure and pause in operations of some direct-to-consumer (DTC) orthodontic companies.  The DTC orthodontic marketplace continues to remain active and the need for strong patient protections through federal and state public policy is urgent. The AAO will continue to actively work with AAO members and coalition partners through grassroots engagement in Washington, D.C. and in states to prioritize patient health and safety.”  

Dentsply’s Recent News on Byte Suspension of Sales and Marketing  
In January 2021, Dentsply Sirona announced that the company acquired Byte and expanded their business into the direct-to-consumer clear aligner market.

In October 2024, Dentsply Sirona announced in a press release, ‘… the suspension of sales and marketing of its Byte Aligners and Impression kits while the Company conducts a review of certain regulatory requirements related to these products.”

Subsequently, the AAO also provided guidance to Byte patients amid the business suspension.

In addition to Dentsply Sirona referencing consultation with the U.S. Food and Drug Administration (FDA) on this Byte business decision, the press release goes on to note:  

“…the state regulatory environment has adversely impacted our Byte Aligner business model, resulting in declining conversion rates, and new documentation, records and additional requirements (such as evidence of visits to a dentist or patient x-rays). As a result, we had begun to assess our resources at Byte to leverage and/or redeploy infrastructure, talent, and capability elsewhere in our business.”

Information was previously reported in the AAO eBulletin regarding the AAO taking a leadership role sharing patient health and safety concerns from a clinical perspective relating to mail-order orthodontic treatment models, by meeting with the U.S. Food and Drug Administration in July 2024.

AAO President Dr. John Callahan commented: “The AAO prioritized sharing clinical concerns related to mail-order orthodontic treatment models with the U.S. Food and Drug Administration last summer. Our concerns were validated by the subsequent announcement that Dentsply Sirona had found that their treatment model ‘…may not provide adequate assurance that certain contraindicated patients do not enter treatment’. Dentsply Sirona also
noted state regulatory trends in announcing their suspension of Byte sales and marketing efforts.”

REQUEST FOR AAO MEMBERS:
Take Action with U.S. Food and Drug Administration Now for Patient Health and Safety Related to Class II Medical Devices (Clear Aligners)  
The work is not done. We need your help through grassroots engagement to support our important state and federal advocacy efforts to protect patient health and safety.”  

Please take action now by visiting the following link and adding your name and address publicly to the letter AAO will be sending the FDA in the coming month to help protect patients: https://p2a.co/2tE6uHI