This will give dentists and their teams an opportunity to pre-empt cavities before they form.
Calcivis uses a novel combination of a medical device and a biologic protein to spot the presence of free calcium ions shed by teeth as they begin to deteriorate.
This can help differentiate between an active lesion and an inactive one – and at their early stages.
The FDA provided the Edinburgh-based company with an approvable letter for the system’s eventual full premarket approval, pending the completion of the required facilities inspections.
The approvable letter is based around positive data from the pivotal clinical study, which evaluated the imaging system in the assessment of active dental demineralisation compared with the current best standard of care.
This new approach is expected to change care planning and intervention for patients, leading to better preservation of their original teeth and improved oral health.
Adam Christie, CEO of Calcivis said: ‘The receipt of an approvable letter from FDA is a very important step as we prepare to launch the Calcivis Imaging System in the world’s largest dentistry market.
'We are confident that Calcivis can help to establish a new standard of preventive care in US dentistry. The System enables clinicians to implement preventive strategies for caries management early in the caries process when it is still reversible, before cavities form.
‘We also know that Calcivis images help patients to understand their condition and to value preventive interventions by their dentist. Our technology helps dentists and patients to collaborate in promoting better oral health.’