FDA Clears Rodo Medical Smilekey Induction Remover
FDA has cleared a Rodo Medical 510(k) for the Rodo Smilekey, an induction remover device for use with the Rodo Abutment System. The device uses Rodo’s proprietary induction technology to remove dental prostheses retained by the Rodo Smileloc in less than 10 seconds without occlusal holes or damaging the prostheses, according to the company. It says the “safe removal of prostheses enables the dentist to provide optimal treatment options and maintenance schedules for patients with implants without incurring excessive chair time and the complications typically associated with screw-retained or cemented prostheses. As part of the FDA clearance, the Smilekey underwent numerous safety tests including thermal and electrical safety testing, electromagnetic compatibility testing, and functional testing with various restorative materials and sizes of restorations.”