The FDA registration permits use of Riva Star as a new generation desensitiser that immediately relieves tooth sensitivity.
SDI previously gained Riva Star registration in several Latin American countries, including Brazil, Peru and Colombia as an anti-caries (decay) agent.
Silver diamine fluoride a key ingredient
The product's key ingredients are silver diamine fluoride (SDF), an antimicrobial solution which stops decay in teeth, and potassium iodide (KI).
A two-step global patented procedure minimises the risk of staining the tooth.
By applying the KI solution over the SDF, a precipitate is formed, which results in a tooth-coloured appearance for the patient.
Tooth decay increasing in some communities
Tooth decay is one of the most common global health problems and recent evidence suggests that the incidence of tooth decay in some communities is growing.
CEO Samantha Cheetham said: “This product is an innovative preventative solution for the company and adds to our leading position in the dental industry globally.
“At this stage, we do not expect it to generate material sales in the short term, as more clinical studies and papers need to be completed from key opinion leaders in the dentistry profession.”