US Marshals, acting under a court order issued by The Food and Drug Administration (FDA), seized $208,910 worth of dental products manufactured by Rite-Dent on January 5th and January 6, 2011. The company, located in Florida, received a warning letter from the FDA back in 2005 citing numerous infractions in the manufacturing facility and was investigated as recently as November 2010. According to the press release issued by the FDA, seized products include Alginate Impression material, Ultra Impression Material, Enamel Bonding System, Pit and Fissure Chemical Curing Sealant, Tooth Shade Resin Material, Cavity Varnish, Polycarboxylate (PCA) Cement, and Zinc Phosphate Cement. The FDA also stated that the manufacturer neglected to obtain FDA marketing approval or clearance for a device called the Ultra Impression System.
What does this mean for you? If you are dentist, the FDA asks that you stop using any of the material listed above that is manufactured by Rite-Dent immediately. If you are a dental patient, your dentist uses products such as the one's listed above on a very regular basis. If you have concerns about the products your dentist uses, and more specifically whether or not the products used during your dental procedure are in fact manufactured by Ride-Dent, call your dental office and ask if they are aware of the recall. If you don't have the opportunity to call before an appointment, don't be afraid to ask your dentist before any work takes place in your mouth. FDA recalls and, in this case the seizure of products, happen for very good reason. It is in your best interest to stay informed.