Manufacturer registered with FDA
Wedent Co., Ltd.
GIMPO-SI, South Korea. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What Wedent Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Wedent interdental brushWedent toothbrush | 2013 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Wedent dental floss | 2013 |
| Tongue ScraperLCN · Class 1 | — | Maker | Wedent Tongue Cleaner | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| WEDENT CO., LTDFDA reg. 3010351588 | Gimpo-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043554). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.