First and Only Dental Laser to Aid in the Reduction of Mineral Loss in Dental Enamel
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Convergent Receives FDA 510(k) Clearance: Reduction of Mineral Loss
By Convergent Dental on October 11, 2022
Needham, MA-Convergent Dental, Inc., the power behind the Solea® All-Tissue Dental Laser, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new, exclusive indication. Solea® is now the first and only laser that is cleared to aid in the reduction of mineral loss in dental enamel, helping to protect teeth against the effects of acid attack and resulting caries development (cavities).
“The significance of this announcement cannot be overstated. While there are decades of research supporting the concept that the structure of dental enamel can be altered using low-level laser energy, at specific wavelength and pulse conditions, to make teeth more resistant to tooth decay, Convergent Dental is the first company that has made the treatment accessible to dentists and patients. Convergent Dental is able to offer this treatment because of their unique patented 9.3 µm carbon dioxide (CO2) laser that is based on many years of research,” said John Featherstone, MSc, PhD, a foremost expert in cariology (study of tooth decay) and Professor Emeritus at the UCSF School of Dentistry. “Despite the dental community’s best efforts with fluoride and sealants, more than half of adolescents aged 12-19 have had cavities and the prevalence of dental caries in adults is over 90%. This new Solea® application has the promise to amplify our ability to ward off future dental decay and promote overall oral health.”“The Solea® platform has proven to be disruptive technology by offering a powerful alternative to the dental drill, scalpel, and use of local anesthetic that appeals to dentists and the patients they treat. The new mineral loss reduction treatment is our latest breakthrough application that supports the expanded use of Solea as a caries prevention tool. This treatment materially expands our total addressable market as it has the potential to be used on most patients treated by the 170,000 general and pediatric dentists in the United States,” said Robert L. Gershon, CEO of Convergent Dental.
The new mineral loss reduction treatment will be made commercially available on a limited basis starting in October of 2022 and fully available in 2023. Convergent Dental also plans to apply for clearance with Health Canada.
About John Featherstone, MSc, PhD | Professor Emeritus University of California, San Francisco John Featherstone, MSc, PhD, is Professor Emeritus of Preventive and Restorative Dental Sciences and Dean Emeritus of the School of Dentistry at the University of California, San Francisco (UCSF). He earned his M.Sc. in physical chemistry from the University of Manchester (UK) and a Ph.D. in chemistry from the University of Wellington (New Zealand). His research over the past 48 years has covered several aspects of cariology (study of tooth decay) including fluoride mechanisms of action, caries risk assessment, de- and remineralization of the teeth, apatite chemistry, salivary dysfunction, and caries prevention. He was a pioneer in research on laser effects on dental hard tissues with emphasis on caries prevention and early caries removal.
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