Manufacturer registered with FDA
Osstem Pharma Co., Ltd.
Ansan-si, South Korea. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What Osstem Pharma 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 |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | WO-200 Osstem Wopick Cordless Oral IrrigatorWO-300 Osstem Wopick Combo Irrigator & Sonic Toothbrush | 2023 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Osstem Double-wide ToothbrushVussen Double-wide ToothbrushVussen Light ToothbrushVussen Ultra Toothbrush | 2020 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | WO-100 Sonic Electric Toothbrush | 2023 |
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 |
|---|---|---|
| Osstem Pharma Co., Ltd.FDA reg. 3016445768 | Ansan-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062264). 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.