QIA — Powered Tongue Scraper Class I
FDA product code QIA covers "Powered Tongue Scraper", a Class I medical device regulated under 21 CFR 872.6865. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QIA
- Device Class
- Class I
- Regulation Number
- 872.6865
- Submission Type
- 510(k) Exempt
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K181986 | Kea Products | Klinly Ultrasonic Tongue Cleaner | Sep 6, 2019 |