(32 days)
- Operates at over 30,000 strokes per minute to help remove plaque bacteria ●
- Sonic waves penetrate beyond the bristle tips, for superior cleaning. .
- Ergonomic design with rubberized Comfort-Grip surface. .
- Two-minute timer helps ensure dentist recommended brush time. .
This 2.4 volt rechargeable battery operated toothbrush is a sonic wave plaque remover with rapidly vibrating bristles that penetrate the most difficult-to-clean areas of your mouth - Places your standard toothbrush might miss. It's also gentle, with seven speeds you can adjust to your own sensitivity level. This effective combination of ergonomics and technology brings you an easy, everyday way to prevent tooth decay and gum disease.
The provided text describes a 510(k) summary statement for a sonic toothbrush, the SonicWave™ Sonic Plaque Remover. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on the device's description, intended use, and a claim of substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The document is a regulatory submission, not a research study report.
§ 872.6865 Powered toothbrush.
(a)
Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement 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 I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.