GreenMark Secures FDA Clearance for LumiCare ™ Caries Detection Rinse

GreenMark Secures FDA Clearance for LumiCare ™ Caries Detection RinseEnhanced Visualization of Dental Caries is the First Commercial Application of Startup Venture ' s Nanotechnology PlatformEast Lansing& Ann Arbor, MI, April 8, 2021–GreenMark Biomedical Inc. announced that the company has secured regulatory clearance from the U.S. Food and Drug Administration (FDA) to market its LumiCare ™ Caries Detection Rinse as a 510(k) Class II Medical Device. " Gaining FDA clearance for our LumiCare ™ device at this particular time is especially gratifying given the significant pandemic challenges of the last year. I need to acknowledge the efforts of the entire GreenMark team and our regulatory partners, " stated Dr. Steven Bloembergen, Ph.D., GreenMark ' s founder, Chairman and CEO. GreenMark plans to commence sales of the product in the fall of this year. Dental Caries, the world ' s most prevalent chronic disease, affects more than 95% of Americans over their lifetimes and when left untreated, can lead to dental cavities. GreenMark ' s LumiCare ™ rinse enhances visualization of carious lesions (cavities& pre-cavities) by targeting and illuminating sub-surface porosities in enamel, thereby aiding in the detection of caries. The technology utilizes bioresorbable starch-based nanoparticles which degrade due to enzymes in saliva by the time the patient is ready to leave the dental office. Validation studies have been performed on a range of caries severity, ...
Source: Dental Technology Blog - Category: Dentistry Source Type: news