Receipt of our first medical device clearance from FDA represents a significant step forward for all of us at Largent Health and would not have been possible without the efforts of our collaborators and partners, both here in the U.S. as well as overseas.
MARIETTA, Ga. (PRWEB) January 23, 2020
Largent Health, LLC announced today receipt of FDA clearance to market FiteBac® Cavity Cleanser with 2% K21. Cavity cleansers are intended for cleansing and moistening/re-wetting of prepared dental surfaces prior to completing a restoration.
Largent Health is a company dedicated to bringing innovative antimicrobial technology to healthcare products. “The clearance of Largent Health’s FiteBac® Cavity Cleanser represents the second FDA regulatory clearance of our FiteBac® technology and the first for our K21 molecule” said Kirk Kimmerling, DDS, Founder and CEO of Kimmerling Holdings Group.
FiteBac® 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 remove debris in carious lesion preparations but also penetrates exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface. Published research supports that a 2% K21 solution is significantly less cytotoxic on human dentin pulp cells than 2% chlorhexidine gluconate, a common component in other cavity cleanser and dental preparations¹.
“Receipt of our first medical device clearance from FDA represents a significant step forward for all of us at Largent Health and would not have been possible without the efforts of our collaborators and partners, both here in the U.S. as well as overseas,” commented John W. Sharkey, Ph.D., CEO of Largent Health LLC. “With the potential for low cytotoxicity and the ability to promote strong binding of adhesives systems to dentin², we believe FiteBac® Cavity Cleanser will become the preferred cavity cleanser for the dental professional.”
To learn more about how FiteBac® technology is being developed for dental applications please visit http://www.FiteBacDental.com.
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. To learn more please visit http://www.LargentHealth.com.
¹ U. Daood, C.K.Y. You. Transdentinal cytotoxicity and macrophage phenotype of a novel quaternary ammonium silane cavity disinfectant. Dent. Materials, v35:2 (206-216) 2019.
² D. Daood, C.K.Y. Yiu, M.F. Burrow, L.-N. Niu, F.R. Tay, Effect of a novel quaternary ammonium silane cavity disinfectant on durability of resin–dentine bond. J. Dentistry, v60 (77-86) 2017.