Sinclair Pharma plc, the British pharmaceutical company developing novel patented products in niche markets, today announces that Decapinol(R), an oral rinse for the treatment and prevention of gingivitis and periodontitis, has been designated as a medical device by the US Food and Drug Administration (“FDA”). The next step is to file for registration of the device so that it can be marketed in the USA. Decapinol(R) is an oral rinse intended for the treatment and prevention of gingivitis and periodontitis. Gingivitis is an inflammation of the gums caused by an accumulation of bacteria within the dental plaque. Gingivitis may progress to periodontitis, where there is loss of attachment between the teeth and surrounding bone. Eventually teeth may be lost. Approximately 60 per cent of the US adult population are estimated to have some degree of gum inflammation.