Nobio Receives FDA Clearances For Infinix™ Flowable And Bulk Fill Composites

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Nobio’s new Infinix™ advanced dental restoratives (both the flowable composite and bulk fill flow composite) have received U.S. FDA clearance. These are the first FDA cleared products incorporating Nobio’s patented QASi particle technology, for maintaining restoration integrity and protecting against bacteria degradation. Two other Infinix™ products with QASi technology are pending FDA clearance (the universal composite and the universal bond) which have an antibacterial cavity cleansing effect.

QASi particles (quaternary ammonium silica-dioxide) are one of Nobio’s groups of antimicrobial particles. These particles combine a high concentration of antimicrobial molecules which are bound to a solid core, forming a solid, long-lasting antimicrobial structure. The antimicrobial action occurs only when bacteria contact the material containing these particles, offering major advantages versus traditional approaches relying on the release of antimicrobial molecules, which can hurt normal flora. Nobio particles 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 on a previous version of QASi, the QPEI particle (quaternized polyethylene-imine), showed strong antibacterial effect in vivo when used 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.

“We’ve been waiting a long time for innovation in the field of composite restorations to preserve the integrity and improve the longevity of restorations. This is particularly important in posterior teeth”, commented John Flucke, DDS, Chief Dental Editor and Technology Editor for Dental Products Report.

According to iData Research, the most impactful factor limiting growth of the U.S. dental prosthetic market is the improvement of oral healthcare, which is lessening demand for dental work. Better dental health will equate to more partially rather than fully edentulous patients. As such, the proportion of partial dentures will grow at the expense of full dentures. Market growth for denture teeth will also slow as partials continue to gain popularity. Relative to full dentures, partial solutions require fewer teeth, averaging around 5.7 on average. As partials continue to grow at the expense of full denture unit sales, the average number of teeth required per denture will fall.

“Preventing recurrent decay is one of the greatest priorities of everyday dentistry. A non-releasing antimicrobial that may act long-term is a promising approach and we look forward to working with these exciting new flowable and bulk fill composites from Nobio and learning how they may benefit our patients,” stated Flucke.


For Further Information

More on the dental prosthetics market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Dental Prosthetics.

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