Biomin F receives FDA 510K approval – the first ever fluoride-containing bioglass toothpaste in USA
Biomin Technologies announces Dr Collins Biomin Restore Plus (Biomin F) toothpaste has FDA 510K approval for relief of sensitivity.
This is a huge breakthrough. It consequently becomes the first fluoride-containing bioactive glass toothpaste to receive approval from the FDA for sale in the United States.
The toothpaste uniquely controls the release of calcium, phosphate and fluoride ions for many hours after brushing. It also helps teeth develop acid-resistant fluorapatite on the tooth surface and inside exposed dentine tubules.
Available only on prescription from registered US dental clinicians, Dr Collins Biomin Restore Plus is based on Biomin F. This is a patented bioactive glass complex developed in the laboratories of Queen Mary University of London, UK, by Professor Robert Hill and his team of material scientists and commercialised by Biomin Technologies Ltd.
The award-winning formulation came into Europe in late 2016. It is now also available in many regions around the world. Biomin Restore Plus is clinically proven to reduce the effects of dentine hypersensitivity and strengthen tooth enamel.
Dr Collins Inc, California, the US license holder, therefore anticipates the product will be available in the US spring 2021.
Californian dental hygienist and dental health educator, Theresa McCarter, has been recommending Biomin toothpastes for some time and reports that it has changed the lives of many most severely affected patients.
She says: ‘I am delighted to see that the fluoride version of Biomin toothpaste is finally becoming available for US clinicians to prescribe for their patients.
‘I feel it is an excellent everyday toothpaste, which will benefit 80-90% of my patients. I am therefore sure this product is a real game changer.’
Biomin’s clinical consultant, Dr David Gillam believes: ‘There are many causes of dentine hypersensitivity. This means that previously no single toothpaste worked for everyone.
‘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. This consequently allows gradual deposition of fluorapatite.’
After brushing with Dr Collins Biomin Restore Plus, the active ingredient adheres to the tooth surface. This controlled release mechanism, continuing to deposit mineral on the tooth surface over several hours, enables Dr Collins Biomin Restore Plus to be more effective at relieving sensitivity than conventional dentifrices, which are rinsed away in around an hour.
Studies at Queen Mary University show that we create new minerals in less than an hour after brushing. The process can continue for up to 12 hours.
Studies around the world also confirm that the fluorapatite developed from Biomin F penetrates deeply inside exposed dentine tubules. It plugs them and prevents the fluid flow which causes dentine hypersensitivity.
In a recent poll undertaken by Biomin Technologies, several hundred dental clinicians report dentine hypersensitivity affects well over 40% of the population. It is most prevalent between the ages of 20-50.
It can range from mild irritation to severe discomfort, affecting quality of life. Response to hot and cold food or drink are the most common symptoms. Nearly half the dental clinicians taking part in the poll feel unsatisfied with their treatment of such cases.
Dr Colin Suzman, a California dentist and board director of Biomin Technologies, says: ‘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 start-up organisation 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 therefore hope to have the product available by end of Q1 2021.’
Dr Collins Biomin Restore Plus toothpaste has a fresh mint taste and leaves the mouth feeling clean and healthy.
For those who prefer a fluoride-free alternative, Dr Collins Biomin Restore toothpaste is also available, with calcium/phosphate bioglass.
Dr Collins Biomin Restore and Restore Plus dentifrices are directly available at biomintoothpaste.com.