Largent Health Announces FDA Clearance for FiteBac® Antimicrobial Cavity Cleanser
For Immediate Release
FiteBac® Cavity Cleanser can not only remove debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface while also helping to reduce the presence of dentally relevant microbes.
Marietta, Georgia (July 7, 2020) Largent Health, LLC announced today a new FDA clearance to market the novel FiteBac® Antimicrobial Cavity Cleanser, with 2% K21. Dental cavity cleansers are used for cleansing and moistening/re-wetting of prepared dental surfaces prior to completion of tooth restoration. The company included in their FDA application, compelling data supporting antimicrobial activity that reduces dentally relevant microbes.
FiteBac® technology exemplifies the marriage of antimicrobial technology to material science, enabling the manufacture of modern materials offering sustained, non-leaching antimicrobial protection across a broad range of products. “The FDA clearance of FiteBac® Antimicrobial Cavity Cleanser represents the second successful FDA regulatory clearance of our FiteBac® technology this year” said John W. Sharkey, Ph.D., CEO of Largent Health, LLC. “This further validates our unique FiteBac® technology and its potential in the development of additional medical products with durable antimicrobial technology built-in”.
FiteBac® Antimicrobial Cavity Cleanser, with 2% K21, is intended to become part of the restoration/dentin interface by copolymerizing with the dental adhesive. Research shows FiteBac® Cavity Cleanser can not only help remove debris in carious lesion preparations but also help reduce the presence of dentally relevant organisms within the prepared tooth structure and to penetrate exposed dentin tubules, allowing restorative adhesives to tightly bind to the prepared dentin surface.
“With receipt of FDA clearance in hand, we look forward to implementing production scale-up and pre-launch activities over the coming weeks”, said Jude Dinges, Chief Commercial Officer at Largent Health. “With the introduction of FiteBac® Antimicrobial Cavity Cleanser, we believe we can offer dentists a differentiated product to help the dental professional ensure the restoration site is clear of carious debris as well as to assist in directly addressing residual microbial contamination within the prepared tooth structure.”
About Largent Health LLC
Largent Health, LLC , based in Marietta, GA, is a private company dedicated to the research, development and commercialization of innovative healthcare products incorporating FiteBac® technology, a superior approach to antimicrobial protection.