The seizure of dentistry products valued at $208,910 follows an FDA inspection that found deficiencies in the Rite-Dent’s manufacturing processes that may affect the safety and effectiveness of the products.
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, Polycarboxylate (PCA) Cement, and Zinc Phosphate Cement, all used in the practice of dentistry.
FDA’s recent inspection also confirmed that the company had not obtained FDA marketing approval or clearance for Ultra Impression System device and advised health care professionals to discontinue use of the products.
The company also failed to notify the FDA regarding a correction it made to a device, Alginate Impression System.
FDA’s Center for Devices and Radiological Health director Jeffrey Shuren said that the FDA expects medical device producers to follow good manufacturing practice and to obtain clearance or approval of the devices that they market and if firms ignore these requirements, they will take appropriate action to protect public health.
