FDA Clears Infinix™ Antibacterial Universal Bond
Contains Nobio’s QASi technology for anti-bacterial cleansing effect. FDA also cleared Infinix Universal Composite with QASi for maintaining restoration integrity
KADIMA, ISRAEL (October 7, 2019) – Nobio today announced FDA clearance for two new members of its Infinix™ restoratives line: Universal Bond and Universal Composite. Universal Bond features Nobio’s QASi antibacterial technology which provides an antibacterial cleansing effect. The Universal Composite, like the recently cleared Infinix Flowable and Bulk Fill Flow composites, also includes QASi particles for protecting against degradation by bacteria and maintaining restoration integrity. All Infinix products have handling and mechanical properties comparable to some of the most popular marketed brands.
The potential antibacterial benefit of the Infinix™ Universal Composite is the subject of an ongoing clinical trial at the School of Dentistry of the University of California, San Francisco (USCF), led by Peter Rechmann, DMD, PhD, Prof. Dr. med. dent., Professor of Prosthodontics and Director of Clinical Sciences Research Group at the Department of Preventive and Restorative Dental Sciences.
“A restorative composite with long-term anti-bacterial properties may have a significant impact on the longevity of restorations and the preservation of natural teeth”, commented Dr. Rechmann, the principal investigator of the UCSF study. “In our study we use a well-established approach for assessing anti-caries effects of novel materials, and if successful, I believe composites with QASi technology should be part of the standard toolkit of restorative dentistry.”
QASi particles (quaternary ammonium silica-dioxide) are a member of Nobio’s family of antimicrobial particles. Nobio particles have a long-term effect because they are retained in the filling material following polymerization and are insoluble.
Other than the ongoing UCSF study, clinical studies demonstrating that the presence of QASi in these products improves clinical outcomes have not been conducted. However, clinical studies on a predecessor version of QASi, the QPEI particle (quaternized polyethylene-imine), showed strong antibacterial effect in vivo when incorporated into various dental materials.
A Continuing Education (CE) course featuring the Infinix™ technology will be soon available on-line through the ADA’s continuing education program. For updates and more information, visit www.infinix.com and subscribe to the “infinix insiders” newsletter.
Infinix™ is the dental material product line from Nobio Ltd., an advanced materials science company offering novel antimicrobial products and solutions. The health and economic burden of bacteria is enormous, and by some estimates in three decades, resistant bacteria may kill more people than all cancers combined. Nobio’s technology transforms common materials to antimicrobial, indefinitely. Nobio currently focuses on dental applications, where bacteria are the leading cause for failure of most treatments, and medical devices, which are linked with most healthcare associated infections, one of the 10 top causes of deaths in developed countries. Visit www.infinix.com for more information on the Infinix product line, and www.nobio.com for more information on Nobio and its technology.
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