On Jan 5 and 6, all dental products from Florida-based Rite-Dent Mfg Corp, were seized by U.S. Marshals, acting under a court order sought by the FDA.
The seizure of dental supplies and materials, valued at more than $200K, follows an initial 2005 FDA inspection that found significant deficiencies in the Rite-Dent’s manufacturing processes that could affect product safety and efficacy. A warning was issued that year. In the ensuing five+ years, it appears that Rite-Dent hasn’t cleaned up its act. A November 2010 inspection revealed continuing significant deviations from the current good manufacturing practice requirements. FDA's recent inspection also confirmed that the Rite-Dent had not obtained FDA marketing approval or clearance for its Ultra Impression System, and that the company also failed to notify the FDA regarding a correction it made to its Alginate Impression System.
The seized products include Alginate Impression Material, Ultra Impression Material, Enamel Bonding System, Pit and Fissure Chemical Curing Sealant, Tooth Shade Resin Material, Cavity Varnish, and Polycarboxylate and Zinc Phosphate Cements.
So check your shelves and toss ‘em. The FDA advises dentists to discontinue use of an Rite-Dent materials.
And here’s a twist. Rite-Dent also manufactured materials for private labeling. Hmmm.