§ 872.6866 Radiofrequency toothbrush.

(a) Identification. A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay. (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested, and detailed protocols must be provided for each test conducted: (i) Validation of the radiofrequency performance specifications including output power, voltage output, radiofrequency, pulse cycle, waveform, and pulse duration; (ii) Temperature performance testing to evaluate the temperature change of the device, structures of the oral cavity (including skin, tissue, and dental restorations), and toothpaste under worst-case conditions; (iii) An assessment of mechanical output specifications and physical properties including vibration frequency, tuft retention, brush head strength, and battery voltage; and (iv) Use life and durability testing. (2) A label comprehension and self-selection study must demonstrate that the intended user population can understand the package labeling and correctly choose the device for the indicated use. (3) Usability performance evaluation must demonstrate that the user can safely and correctly use the device, based solely on reading the directions for use. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Electrical safety, thermal safety, mechanical safety, battery safety, and electromagnetic compatibility (EMC) testing must be performed. (6) Software verification, validation, and hazard analysis must be performed. (7) Labeling must include: (i) Information on how the device operates, including images or illustrations; (ii) A detailed summary of the device technical specifications; (iii) A warning which states that the use of this device is not a substitute for regular visits to a dentist for routine clinical care; (iv) Instructions on how to clean and maintain the device; and (v) The use life and disposal of the components of the device.