FDA Approves Smilekey®, a Much Anticipated Smileloc® Induction Remover Device by Rodo Medical, Inc.
Published: Jun 04, 2018
SAN JOSE, Calif., June 4, 2018 /PRNewswire/ -- Rodo Medical, Inc. , an innovative dental device company, announces FDA 510(k) clearance of the Rodo Smilekey, an induction remover device for use with the Rodo Abutment System.
The Smilekey 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. The Smilekey greatly enhances the patient and practitioner experience with the Rodo Abutment System by providing safe and easy removal of single-tooth restorations and multi-unit-prostheses. This fast, easy, and 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.
The Smilekey will be available initially to current Rodo customers in July 2018, and then to the broader US market and other select countries later this year. For more information, please contact Veronika Jedlicka, Director of Customer Experience at email@example.com.
About Rodo Medical, Inc.
Rodo Medical is an innovative dental device company dedicated to improving restorative procedures for patients and dentists with its novel retention and removal devices. Rodo Medical is a privately held company based in San Jose, CA. For more information, please visit www.rodomedical.com.
Media Contact: Veronika Jedlicka, Rodo Medical, Inc., 408.245.7636, firstname.lastname@example.org
SOURCE Rodo Medical, Inc.