DeviceClearance

Product code QMJ— Dental

Silkn Toothwave

Classification name
Powered Radiofrequency Toothbrush
Device class
Class 2
Regulation
21 CFR 872.6866
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QMJ under 21 CFR 872.6866, via openFDA

Market context for product code QMJ

FDA has cleared 2 devices under product code QMJ between 2020 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QMJ

Recent clearances under product code QMJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.