Manufacturer registered with FDA
DRTECH Corporation
Seongnam-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 12024–2024
- Markets registered in
- 1448 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 14 markets
Where regulators' registries name DRTECH Corporation 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 | DRTECH Corporation | 1 clearances | 2024–2024 | Below |
| European Union | EUDAMED | Manufacturer | DRTECH Corporation | 10 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DRTECH CORPORATION | 7 | 2016–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | DRTECH CORPORATION | 5 | 2012–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DRTECH CorporationDRTECH CO. · DRtech Corporation | 5 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DRTECH CORPORATION | 4 | 2018–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DRTECH CORPORATION | 4 | 2019–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DRTECH CORPORATIONDRTECH | 3 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | DRTECH Corporation | 3 | 2025–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | DRTECH Corporation | 2 | 2020–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | DRTECH Corporation | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | DRTECH Corporation | 1 | — | Pure Global AI |
| Tanzania | TMDA | Manufacturer | DRTECH Corporation | 1 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | DRTECH Corporation | 1 | — | 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 DRTECH Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | XERO ? | 2024 |
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 |
|---|---|---|
| DRTECH CorporationFDA reg. 3005172103 | Seongnam-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9073399). 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.