The Justice Department has filed a complaint seeking to permanently bar a Nevada dental product manufacturer from making and selling its products after the FDA allegedly found the company in violation of federal law.
The Aug. 6 complaint names CEO Greg Steiner, DDS, Roslynn Steiner, and Steiner Biotechnology, alleging violations of the Federal Food, Drug, and Cosmetic Act. The products at issue include synthetic bone grafting materials and dental cement.
The FDA allegedly inspected Steiner Biotechnology’s facility at least four times between 2018 and 2025, finding repeated failures including inadequate manufacturing controls, insufficient process validation, failure to investigate nonconformities and failure to obtain FDA premarket approval for the sale of certain medical devices. Despite multiple warnings and the Steiners’ repeated promises to comply, the violations allegedly continued, according to the news release.
The government is seeking injunctive relief requiring the company to implement manufacturing and sanitation improvements and comply with federal requirements before distributing any additional dental products.
“SteinerBio has been in business for 20 years manufacturing regenerative products for the maxillofacial region. We have a perfect safety record,” Dr. Steiner said in an emailed statement to Becker’s. “There has never been an adverse event reported regarding our products. The FDA has never found a defect with any of our products and there has never been a recall of any of our products. The FDA saying our products are adulterated has nothing to do with our products, but they make this egregious statement based on paperwork that has nothing to do with our products.”
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