Data / Medical devices / Powered Tongue Scraper
Powered Tongue Scraper (QIA): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Powered Tongue Scraper (product code QIA, Class 1, 21 CFR 872.6865). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on September 6, 2019, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QIA
- Device class
- 1
- Regulation
- 872.6865
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| Taiwan | 1 |
| South Korea | 1 |
| United States | 1 |
Makers of Powered Tongue Scraper
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| BSD Product Design Inc. | Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanning Sixtant Biotechnology Co., Ltd | Nanning Guangxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Proxihealthcare | Ulsan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qibei Technology Co., Limited | KL Hong Kong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qingdao S&R Industry And Trade Co Ltd | QINGDAO Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Ainengke Electronics Co, Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Slate Dental, Inc. | Spokane, WA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 6, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.