Nobio receives FDA Clearance for Infinix Flowable and Bulk Fill Composites

Nobio receives FDA Clearance for Infinix Flowable and Bulk Fill Composites
Posted: August 7, 2019 / Source: Infinix Press Release

Edited by Dentaltown staff

TEL-AVIV, ISRAEL—Nobio’s Infinix advanced dental restoratives—Flowable Composite and Bulk Fill Flow Composite—have received U.S. FDA clearance to market. These are the first FDA-cleared products incorporating Nobio’s patented QASi particle technology for maintaining restoration integrity and protecting against degradation by bacteria over time. Two other Infinix products with QASi technology are pending FDA clearance, the Universal Composite, and the Universal Bond, which has an antibacterial cavity cleansing effect.

More than 200 million tooth restorations are performed each year in the U.S., most of them to replace existing restorations that fail due to bacteria that penetrate the tooth-restoration interface (e.g. the micro-gap between the restoration and tooth, a common site of recurrent decay). The estimated annual cost of replacement dentistry is over $5 billion.

QASi particles (quaternary ammonium silica-dioxide) are a member of Nobio’s family of antimicrobial particles. These particles combine a high concentration of antimicrobial molecules which are covalently bound to a solid core, forming an insoluble, potent, long-lasting antimicrobial structure. The antimicrobial effect occurs only when bacteria contact the material containing these particles, offering significant advantages versus traditional approaches relying on the release of antimicrobial molecules, which eventually deplete and may affect also normal flora. Nobio particles have a long-term effect because they are retained in the filling material following polymerization and are insoluble. Long-term antimicrobial protection and a stable molecular structure are especially important in dental restorations which are intended to remain in the oral environment for decades.

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 different dental materials. Two other clinical studies have been initiated in the U.S. and Israel to demonstrate the potential benefit and duration of the antimicrobial effect of the Nobio QASi technology used in the Infinix product line.

Nobio is offering an accredited Continuing Education course featuring the Infinix technology on September 6, at the upcoming American Dental Association annual meeting in San Francisco. The company is also evaluating strategic relationships with several major dental industry companies for the Infinix composite line and technology licensing in preparation for a launch later in 2019.

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