Manufacturer registered with FDA
Unidental Co., Ltd.
Gwangmyeong-si, South Korea. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 22023–2026
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Unidental 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 | Unidental Co., Ltd. | 2 clearances | 2023–2026 | Below |
| Australia | TGA | Registration holder | Unidental Pty Ltd | 3 | 2017–2024 | 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 Unidental 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | UNIdental Symphony Implant System | 2023 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | UNIdental Symphony Implant System | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Unidental Co., Ltd. as the applicant, including filings under its other names.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| UNIDENTAL.CO.KRFDA reg. 3029973218 | Gwangmyeong-si Gyeonggi, South Korea | Manufacturer |
Other names on FDA records
Unidental.co.kr
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089087). 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.