Nobio’s Antibacterial Composites Receive FDA 510(k) Clearance for Addressing a Key Process in Tooth Decay
Clinical data show that Infinix composites significantly reduce tooth demineralization
Kadima, Israel – September 8, 2020 — Nobio Ltd. today announced it has received an additional FDA 510(k) clearance 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-formation (tooth decay) process. Read more at FDAnews.com.
“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, PhD, 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.
Prof. Ervin Weiss, DMD, Nobio’s CTO and co-founder, and Dean Emeritus of the School of Dentistry of Tel-Aviv University, added, “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.”
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 www.Infinix.com.
Nobio is a material sciences company that redefines the field of antimicrobial products and solutions with its long-lasting, safe, and highly active novel particle technology. Nobio developed and is commercializing Infinix, the first line of dental materials with its revolutionary antimicrobial technology to address the main causes of dental treatment failure and tooth loss. Nobio is also working with leading medical, dental, consumer, and industrial manufacturers to bring long-lasting antimicrobial properties to a wide range of products and applications.
The information stated above was prepared by Nobio to report on research conducted on its product and reflects solely the opinion of Nobio. Nothing in this statement shall be construed to imply any support or endorsement of Nobio, or any of its products, by The Regents of the University of California, its officers, agents, and employees.
Scott Maier, UCSF