The FDA exists to keep patients safe by ensuring – through rigorous regulatory oversight – the safety and efficacy of medical devices sold in the United States. Second Opinion® is the first-ever clinical AI software that the FDA deemed safe and effective as a chairside disease detection aid for dentists.
An AI detection system cannot be used in clinical care and patient communication until each of its detection capabilities has been cleared by the FDA.
The other dental AI solutions out there have been cleared to detect just one condition in permanent teeth – caries – in bitewing radiographs, and can only be used with patients 18 (or 22) and older.
Second Opinion® is cleared to detect caries plus eight additional conditions in permanent teeth in both bitewing and periapical radiographs of patients 12 and older. This makes Second Opinion® the most powerful patient-facing AI assistant available—and by far the most useful.