Nevada Company Is in Hot Water Again for Selling Adulterated Dental Products
The US Department of Justice is suing the company for selling adulterated or misbranded dental products, and it’s not the organization’s first offense.
Steiner Biotechnology in Henderson, Nevada, a suburb of Las Vegas, has been charged with selling adulterated or misbranded dental products. The most terrifying part is that the products under scrutiny include synthetic bone grafting materials and dental cement, putting patient safety at definite risk. The company’s products are currently sold throughout the United States.
The charges assert that products sold by Steiner Biotechnology do not meet the minimum guidelines for manufacturing and quality as set by the US Food and Drug Administration. The lawsuit was filed after an inspection conducted in February found the company was in violation of many of the FDA’s regulations.
The lawsuit also accused the company of altering devices that it does not have the required clearance to sell. For instance, the composition of Socket Graft Plus, a premixed, dual-phase calcium phosphate biocement combined with third-generation β-TCP granules, designed for dental socket regeneration and preservation after tooth extraction, was changed without first receiving FDA approval.
Steiner Biotechnology has received many violations during previous inspections in 2018, 2022, and 2024. The lawsuit asks that the company be prohibited from manufacturing, processing, packing, holding, labeling, or distributing any device until its operation meets all FDA regulations. Click here to read more.
