Ortek Therapeutics Receives FDA Clearance for Cavity Detection Device
Ortek Therapeutics received 510(k) clearance for its electronic dental cavity detection device. The tabletop unit allows dental professionals to diagnose and monitor cavities in the biting surfaces of molars and premolars.
The device detects tiny lesions in the tooth enamel before a cavity is formed, and measures the amount of dentinal fluid in the pits and fissures of molars and premolars.
Tooth enamel is electrically non-conductive unless breached by fracture or demineralization. The more fluid the device detects, the greater the severity of the lesion.