Under the oversight role of the Saudi Food and Drug Authority to ensure the safety, effectiveness and quality of medical devices and their effect on patients; counterfeit Endodontic files marketed as genuine devices- that were manufactured by DENSPLY , have been captured by the SFDA inspectors. These counterfeit devices can be detected by noticing the differences in labels, packaging and the file design. Due to the potentiality of breaking the counterfeit file into the patient tooth during treatment, the SFDA has addressed the concerned authorities to prevent the entry of this device, and to withdrawal it from the market, and to prevent selling this device, and to apply all the necessary statutory procedures on every importer or distributor of this counterfeit device.


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