Dr. Collins has announced FDA approval of its BioMin Restore Plus toothpaste for hypersensitivity.
Dr. Collins has announced its new BioMin Restore Plus Toothpaste has received FDA 510K approval for sensitivity relief. Reportedly the first fluoride-containing bioactive glass toothpaste to be approved for sale in the US, BioMin Restore Plus is available by prescription only.
The toothpaste is designed to control the release of calcium, phosphate, and fluoride ions for hours after brushing, which is said to develop acid-resistant fluorapatite on the tooth surface and inside exposed dentin tubules. BioMin Restore Plus is based on BioMin® F, a patented bioactive glass complex developed at Queen Mary University of London.
After brushing, BioMin Restore Plus’ active ingredient adheres to the tooth’s surface, where microscopic particles slowly dissolve over an 8 to 12 hour period. During this dissolving period, the particles are constantly releasing calcium, phosphate, and fluoride ions. These combine to deposit fluorapatite, which is similar to natural tooth enamel but is said to be more acid-resistant. It’s also designed to fill any exposed dentin tubules, plugging them to prevent the fluid flow which can cause hypersensitivity.
“There are many causes of dentine hypersensitivity which means that previously no single toothpaste worked for everyone,” said Dr. David Gillam, BioMin’s clinical consultant. “One of the advantages of BioMin is that it provides a constant supply of low levels of fluoride, calcium, and phosphate in the biofilm/saliva/dental interface, which allows fluorapatite to be deposited gradually.”
“We are delighted that the FDA has given us the approval to provide BioMin Restore Plus toothpaste to the American public via the dental profession,” said Dr. Colin Suzman, founder of Dr. Collins, Inc. “It is a real achievement for a start-up organization to achieve this result. We believe this ground-breaking technology will bring considerable benefit to many sufferers of dentine hypersensitivity. We are now proceeding to full production and hope to have the product available by end of Q1 2021.”