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Online ISSN 1827-174X
Fonzi M., Fonzi L., Lungarella G., Lafornara D., Bertelli E.
At the moment, in most countries, there are laws in force which impose to the manufacturers well regulated testing in order to investigate and guarantee an acceptable biocompatibility of medical devices before their commercialization. Many international laboratories are committed to the definition of investigation methodologies and to the evaluation of biocompatibility in order to obtain research standards, capable to provide reproducible and comparable objective quantitative data. In every country, technical committees were put together for a standardization of methodological procedures, followed by European and international technical boards which proposed and codified methodologies and investigation approaches. UNI-EN-ISO laws contain all the results and constitute a reference point for any consideration on or evaluation of the biocompatibility of a medical device. Based on these laws, we evaluated the biocompatibility and determined the physical-mechanical characteristics of the new Venezia (Cabon S.p.A.) endodontic ZOE sealer. The Subcutaneous Implant Technique according Safavi et al. (in vivo test, ISO 10993: 1-6 Biological evaluation of medical and dental materials and devices) and Autian test of Emolysis on Rabbit Erythrocytes (in vitro test) allowed us to evaluate a good biocompatibility of the new product. Furthermore, its Setting and Working time, its radiopacity, Solubility and its Flow value completely satisfy the requirements of international standards (ISO/DIS 6876 Dental root Canal Sealing Materials). We can finally deduce that Venezia fulfil the ideal functional properties of an endodontic cements.