Largent Health Announces FDA Clearance for FiteBac® Antimicrobial Cavity Cleanser
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.
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 2nd 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 can now offer dentists a differentiated product to both help the dental professional ensure the restoration site is clear of carious debris and assist in addressing residual microbial contamination within the restoration site.”
To learn more about how FiteBac® technology is being developed for medical applications please visit http://www.LargentHealth.com