Unapproved Class III Dental Devices Circulated Nationwide for Seven Years; DOJ Sues Manufacturer Seeking Permanent Injunction

Source: U.S. Department of Justice

DentalGoodNews｜On August 6, 2026, local time, the U.S. Department of Justice (DOJ) filed a civil complaint in the U.S. District Court for the District of Nevada, seeking a permanent injunction against dental medical device manufacturer Steiner Biotechnology LLC (hereinafter referred to as "Steiner") and its co-owners. The complaint alleges that Steiner distributed adulterated and misbranded medical devices nationwide, including certain Class III dental devices that did not meet premarket authorization requirements, in persistent violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and Current Good Manufacturing Practice (CGMP) requirements.

According to a warning letter issued by the FDA in May 2023, the products involved include synthetic bone graft materials and dental cements, specifically models such as Socket Graft Plus, Socket Graft Injectable, Immediate Graft, BioDensification, Ridge Graft Kit, Sinus Graft, OsseoConduct, and Oral Bond. FDA investigators conducted multiple inspections of the company's facilities between 2018 and 2025, identifying repeated violations in its Quality System (QS) and manufacturing practices.

Specific violations include: failure to establish adequate procedures for controlling device design, failure to validate manufacturing processes in accordance with procedures, failure to effectively control environmental conditions, and failure to implement effective corrective and preventive actions (CAPA) for non-conforming products and quality issues. Additionally, Steiner is accused of failing to submit identified quality issues and CAPA-related information to management for review. The announcement noted that the FDA had repeatedly warned Steiner that some of its medical devices failed to meet premarket requirements. According to the DOJ announcement, certain Class III devices lacked approved Premarket Approvals (PMA), did not complete cleared Premarket Notifications (510(k)), or lacked valid Investigational Device Exemptions (IDE).

According to public records, Steiner is located in Henderson, Nevada, and is co-owned and operated by Gregory G. Steiner and Roslynn L. Steiner. Its products are sold across the United States, with primary customers including dentists and dental clinics. The FDA had previously issued warnings to the company, including a 2019 warning letter and a 2023 Warning Letter, citing violations of FDCA requirements related to certain devices. Brett A. Shumate, Assistant Attorney General of the DOJ's Civil Division, stated that this enforcement action reflects the Department's commitment to safeguarding patient safety and holding violative medical device manufacturers accountable. Michelle Tarver, Director of the FDA's Center for Devices and Radiological Health, also stated that the FDA will continue to hold manufacturers accountable for failing to meet federal requirements to protect public health.

Currently, the permanent injunction sought by the DOJ would require Steiner to complete sanitation and process improvements and fully comply with the FDCA and applicable medical device regulations before continuing to manufacture or distribute any dental products. As of press time, Steiner has not publicly responded to the aforementioned lawsuit and injunction request.