BioMin F toothpaste receives FDA 510(k) approval

Dental Tribune International

Thu. 24 December 2020

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SILVER SPRING, Md., U.S./LONDON, U.K.: BioMin Technologies has announced that its BioMin Restore Plus toothpaste has received 510(k) clearance from the Food and Drug Administration (FDA) for relief of dentine hypersensitivity. The toothpaste is available only on prescription from registered U.S. dental clinicians and is based on BioMin F, a patented bioactive glass complex developed in the laboratories of Queen Mary University of London in the U.K. Dr.Collins, the U.S. license holder, anticipates that the product will become available in the country in spring 2021.

“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. It is a real accomplishment for a startup organization to achieve this result. We believe this ground-breaking technology will bring considerable benefit to many sufferers of dentine hypersensitivity,” said Dr. Colin Suzman, a California-based dentist and board director of BioMin Technologies.

Established in 2014, BioMin Technologies, a Queen Mary spin-off, introduced the first toothpaste containing bioactive glass to the public in 2016. It was developed to adhere to tooth structure through a special polymer, and to slowly dissolve calcium, phosphate and fluoride ions over an 8–12-hour period after brushing in order to develop acid resistant fluorapatite on the tooth surface and inside exposed dentine tubules. It went into commercial production the same year and is now available in many regions around the world. BioMin F was the first toothpaste to gain accreditation from the Oral Health Foundation’s expert panel for both sensitivity reduction and remineralization. A fluoride-free version of the toothpaste, based on a calcium-phosphate bioglass, was introduced in Europe in 2017 under the name of BioMin C. In 2020, the range of BioMin products was further extended with the introduction of BioMin F for Kids to provide protection and remineralization of children’s teeth. Products in the BioMin range are vegan as they contain no animal-derived materials and no animal testing has been used in their development.

Several scientific and clinical studies have proven the effectiveness of the technology in the treatment of dentine hypersensitivity. In an article published this year in Dental Tribune International’s prevention magazine, Drs. Stefano Daniele and Andrea Alessandri from Italy described the results of a clinical trial. They found that 27.58% of patients treated with BioMin F for two weeks reported an elimination of hypersensitivity, while in 52.72%, the pain had been significantly reduced.

Theresa McCarter, a Californian dental hygienist and dental health educator, commented: “I am delighted to see that the fluoride version of BioMin toothpaste is finally becoming available for U.S. clinicians to prescribe for their patients. I feel it is an excellent everyday toothpaste which will benefit 80–90% of my patients. I am sure this product will become a real gamechanger.”

According to FDI World Dental Federation, dentine hypersensitivity occurs in 3–57% of adults. In general, patients with periodontitis have a relatively higher prevalence of dentin hypersensitivity. Most likely owing to the factors including acidic diets and inappropriate use of tooth whitening products, an increasing number of young adults have presented with dentin hypersensitivity in recent years.

Dr.Collins BioMin Restore and Restore Plus dentifrices are directly available at https://biomintoothpaste.com.

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One thought on “First fluoride-containing bioglass toothpaste cleared for sale in the U.S.”

Kelly says:

May 20, 2021 at 2:49 pm

Can someone please let me know if and when Biomin F is available to purchase in the USA? If so, where can I buy it? I want to make sure I get the real thing. I have a hairline crack in my front tooth caused by invisible tooth aligners. I want to see if this can fix that before I go any other route. Thank you so much.