(408 days)
The Klinly Ultrasonic Tongue Cleaner is indicated to reduce plaque, food debris, and bacteria from the surface of the tongue, and also to help fight bad breath and promote oral hygiene.
The Klinly Ultrasonic Tongue Cleaner is a battery-operated device intended to be used to supplement daily oral hygiene care. It operates on two (2) AAA Alkaline batteries. All user-contacting components of the Klinly Ultrasonic Tongue Cleaner are constructed of injection-molded plastics which have demonstrated substantially equivalent biocompatibility according to ISO 10993-1.
The Klinly Ultrasound Tongue Cleaner device is comprised of three principles of operation to supplement daily oral hygiene by tongue cleaning. The device has a tongue scraping head, which:
- (1) Operates manually as a standard manual tonque scraper
- (2) Produces a low-frequency tactile vibration at 233 Hz, and
- (3) Emits ultrasound pressure waves at 1.6 MHz frequency.
The acceptance criteria and the study proving the device meets them are described below for the Klinly Ultrasonic Tongue Cleaner.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Measured Outcome) | Performance Requirement (Implicit) | Reported Device Performance | p-value (Statistical Significance) |
|---|---|---|---|
| Breath Malodor Reduction | Significant reduction in breath malodor | 37% reduction in breath malodor | p=0.0002 |
| Tongue Plaque Reduction | Significant reduction in tongue plaque | 41% reduction in tongue plaque | p |
§ 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.