QIA · Powered Tongue Scraper
Dental · 21 CFR 872.6865 · Class 1
Overview
| Product Code | QIA |
|---|---|
| Device Name | Powered Tongue Scraper |
| Regulation | 21 CFR 872.6865 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Classification Rationale
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K181986 | Klinly Ultrasonic Tongue Cleaner | Kea Products, Ltd. | Sep 6, 2019 | SESE |
Top Applicants
- Kea Products, Ltd. — 1 clearance
