Rite-Dent Dental Products Seized by FDA

About $200,000 in dental products made by Rite-Dent Manufacturing Corp. were seized by U.S. Marshals after federal regulators determined that they were unsafe for public use. 

The FDA ordered the seizure of all dental devices from Rite-Dent earlier this month after an FDA inspection found significant manufacturing deficiencies that made the safety and effectiveness of the products uncertain. The seizure followed a series of warnings as a result of FDA inspections that go back to 2005. The most recent inspection of the Hialeah, Florida-based company was in November 2010.

Products seized by U.S. Marshals include the following dentistry devices and substances:

• Alginate Impression Material
• Ultra Impression Material
• Enamel Bonding System
• Pit and Fissure Chemical Curing Sealant
• Tooth Shade Resin Material
• Cavity Varnish, Polycarboxylate (PCA) Cement
• Zinc Phosphate Cement

When the FDA first inspected the company back in 2005, investigators found that Rite-Dent essentially had no quality control measures in place. It had not conducted a quality audit, did not have a quality control policy or commitment, failed to validate certain blending, mixing and filling operations, and had no system for corrective actions.

During the last inspection, FDA investigators found that the company had released the Ultra Impression System without obtaining FDA clearance or marketing approval, and failed to notify the agency of changes to the Alginate Impression System. In addition, the FDA inspectors said that the company still had significant deviations from current good manufacturing practice requirements.

The FDA is advising dentists and other health care professionals to discontinue use of all of all products by Rite-Dent.