U.S. Marshals Seize Dental Products from Florida Firm

U.S. Marshals have confiscated unapproved dental devices and fixation materials from a Florida company that blatantly disregarded warnings about the safety of its products and quality system by U.S. Food and Drug Administration (FDA) officials.

Acting under FDA court-ordered instruction, U.S. marshals seized a bevy of dental tools and bonding materials from Rite-Dent Manufacturing Corporation, including Alginate Impression material; Ultra Impression material; Enamel Bonding System; Pit and Fissure Chemical Curing Sealant; Tooth Shade Resin material; Cavity Varnish, Polycarboxylate Cement; and Zinc Phosphate Cement. FDA executives allege the products pose significant health and safety risks, noting the company failed to obtain the proper permits for the Ultra Impression System (used to make casts of the teeth and mouth), and did not notify the agency of changes to its Alginate Impression System.

The seizure of products from Rite-Dent’s manufacturing operations in Hialeah, Fla., caps a five-year struggle by the FDA to force the firm to correct problems with its quality system and comply with 21 CFR 820 and federal medical device reporting requirements. The FDA sent two separate warning letters to the firm (spaced five years apart) listing violations to the Quality System Regulation and cautioned that the breaches could cause its devices to become adulterated and misbranded.

Some of the problems with Rite-Dent’s quality system included:

• Failing to establish procedures for quality audits and conduct such audits. In its first warning letter, dated Dec. 2, 2005, the FDA claimed Rite-Dent had never conducted a quality audit up to that time;
• Failing to establish a policy and objectives for—as well as a commitment to—quality;
• Failing to establish and implement complaint handling procedures;
• Failing to establish and maintain procedures for implementing corrective and preventative action. In that same letter (Dec. 2, 2005), the FDA again accuses Rite-Dent management of “never” initiating corrective or preventative actions;
• Failing to establish and maintain procedures for identifying product during all stages of receipt, production and distribution;
• Failing to develop, conduct, control and monitor production processes. “There were no written procedures covering the completion of dental impression material and cement during curing tests,” the FDA’s 2005 warning letter stated;
• Failing to establish and maintain procedures to control labeling activities;
• Failing to establish or maintain device history records; and
• Failing to develop, maintain and implement written Medical Device Reporting procedures

“The FDA expects medical device producers to follow good manufacturing practice and to obtain clearance or approval of the devices that they market,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “If firms ignore these requirements, we will take appropriate action to protect public health.”

In this case, the FDA’s “appropriate action” was last month’s seizure of Rite-Dent’s products and a general warning to dentists and orthodontists against using any of the company’s devices or materials. The agency claims any teeth cleaning, polishing, fillings, caps, sealants, crowns, bridges, oral treatments, braces, dental or mouth hardware as well as dental implants potentially could be impacted by Rite-Dent’s failure to adhere to federal regulations.