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GreenMark Secures FDA Clearance for LumiCare™ Caries Detection Rinse
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EAST LANSING, Mich. and ANN ARBOR, Mich., April 8, 2021 /PRNewswire/
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.