Nobio has received FDA 510(k) clearance for its Infinix line of composites.
Nobio Ltd. announced it has received an additional 510(k) clearance from the U.S. Food and Drug Administration for the company’s Infinix™ family of dental composites. Clinical data supporting the company’s submission to the FDA demonstrated that Nobio Infinix antibacterial composites significantly reduce tooth demineralization, which is part of the caries-formulation process, the company said in a press release.
“The data further validates our technology which promises a breakthrough in restorative dentistry improving outcomes for dentists and their patients,” said Yoram Ashery, Nobio CEO. Nobio’s Infinix composites incorporate its patented QASi™ particle technology, which has shown long-lasting inhibition of bacterial growth at the margins of composite fillings. “Infinix gives dentists a new tool to fight recurrent caries which is the main cause of restoration failure,” said Ashery.
Tooth decay is a process, where bacteria generate acids that dissolve teeth by causing demineralization (tooth mineral loss), which leads to cavitated lesions (caries). Recurrent caries, tooth decay that occurs under existing fillings, crowns, or onlays, is a major cause of premature restoration failure.
A clinical study was performed at the University of California, San Francisco (UCSF) to assess Infinix’ s antibacterial activity in slowing and reducing demineralization. This study, completed in March, was led by principal investigator Peter Rechmann, DMD, Ph.D., professor and director of the Clinical Sciences Research Group at the UCSF School of Dentistry, and President of the American Academy of Cariology. “Our study showed that mineral loss in teeth adjacent to Infinix composites was two-thirds less than for the standard composite material, indicating the potential for less recurrent decay, longer-lasting restorations, and less natural tooth loss”, said Dr. Rechmann.
“We believe Infinix is a major advancement for dentistry that will reduce the likelihood of restoration failures due to secondary caries with its associated discomfort and costs,” added Prof. Ervin Weiss, DMD, Nobio’s CTO and co-founder, and Dean Emeritus of the School of Dentistry of Tel-Aviv University.
Nobio plans to initiate commercial sales of its Infinix product line by the end of this year. Dentists interested in trying Infinix composites can reserve a free Starter Kit at infinix.com.