Tag: resin-material

Dentists Urged to Stop Using Product Manufactured by Rite-Dent

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. … Read Full Post