| Device |
powered radiofrequency toothbrush |
| Definition |
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. |
| Physical State |
The device is a handheld rechargeable powered toothbrush comprised of the handle, the brush head, and recharging unit. The brush head is designed with radiofrequency electrodes and bristles. The handheld unit contains the software, programming, and hardware necessary for the device to function. The device is operated by a push button for activation of the radiofrequency and vibration. |
| Technical Method |
The device utilizes tactile vibration and low power conductive radiofrequencies to deliver vibration frequency and low power radiofrequency energy to the surface of the teeth to remove adhered plaque and food debris from the teeth. |
| Target Area |
Oral cavity of the mouth |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | QMJ |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
872.6866
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
