Manufacturer registered with FDA
EPDENT Co., Ltd.
Gimpo Si, South Korea. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1South Korea
Registered in 3 markets
Where regulators' registries name EPDENT Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | EPDENT Co., Ltd. | 6 device types | — | Below |
| Taiwan | TFDA | Manufacturer | EPdent Co., Ltd. | 2 | 2018–2018 | Pure Global AI |
| Australia | TGA | Manufacturer | EPDENT Co Ltd | 1 | 2024–2024 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What EPDENT 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | — | 2018 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | — | 2018 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | — | 2022 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | — | 2022 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | — | 2018 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | — | 2017 |
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 |
|---|---|---|
| EPDENT CO., LTD.FDA reg. 3013734586 | Gimpo-city Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10055507). 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.