Miscellaneous devices · 21 CFR 872 Subpart G
Powered Tongue Scraper
The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care.
- Companies listing it
- 87 makers
- Brands and models
- 10
- 510(k) clearances
- 10 in five years
- FDA name
- Powered Tongue Scraper
510(k) clearances per year, 1976–2026
Companies that list QIA
8 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Qibei Technology Co., Limited | China | Maker | Tongue scraper · TS01,TS02,TS03,TS04,TS05,TS06,TS07,TS08,TS09,TS10GS01,GS02,GS03,GS04,GS05,GS06,GS07,GS08,,GS09 | — | — |
| Shenzhen Ainengke Electronics Co., Ltd. | China | Maker | Household Tooth Polisher: X1Pro, X2Pro, X3Pro, X4Pro, X5Pro, X6Pro, X7Pro, X8Pro, X9Pro, X10Pro, X11Pro, X12Pro | — | — |
| BSD Product Design Inc. | Taiwan | Maker | Powered Tongue Scraper · Powered Toothbrush | — | — |
| Proxihealthcare | South Korea | Maker | TROMATZ-O | — | — |
| Qingdao S&R Industry and Trade Co. Ltd | China | Maker | power tongue cleaner | — | — |
| Slate Dental, Inc. | United States | Maker | Slate Electric Flosser | — | — |
| Nanning Sixtant Biotechnology Co., Ltd | China | Maker | Tooth paste | — | — |
| battech | United States | Repacker / relabeler | dental stainless steel tongue scraper | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 6 Sep 2019 | K181986 | Klinly Ultrasonic Tongue Cleaner | Kea Products, Ltd. |
Official records: FDA product classification for QIA · 21 CFR 872.6865.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026