Manufacturer registered with FDA
VATECH Co., Ltd.
Hwaseong-si, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 33 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 332008–2026
- Markets registered in
- 14168 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 14 markets
Where regulators' registries name VATECH Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: South KoreaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | VATECH Co., Ltd. | 33 clearances | 2008–2026 | Below |
| Canada | Health Canada | Registration holder | VATECH CO., LTD.VATECH CO.,LTD. | 47 | 2008–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Vatech Co., Ltd.VATECH CO., LTD · VATECH Co., Ltd. | 28 | 2007–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Vatech Co., Ltd. | 20 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | VATECH Co.,Ltd.VATECH CO., LTD. · Vatech · +1 | 14 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | VATECH CO., LTD.VATECH CO. LTD. | 10 | 2016–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | VATECH Co., Ltd. | 10 | 2024–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | VATECH Co., Ltd. | 9 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Vatech Co Ltd | 8 | 2012–2022 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | VATECH CO., LTD | 8 | 2014–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | VATECH Co., Ltd.Vatech Co., Ltd · VATECH CO., LTD | 6 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | VATECH Co., Ltd. | 4 | — | Pure Global AI |
| China | NMPA | Registration holder | 瓦泰克有限公司VATECH Co.,Ltd.瓦泰克有限公司VATECH Co., Ltd. | 3 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | VATECH Co., Ltd. | 1 | 2026–2026 | 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 VATECH 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 Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | Green X 12 Plus / Green X Plus (Model: PHT-70CHS)Green X 12 SE (Model : PHT-40CHS)Green X 21 (Model : PHT-90CHO) | 2012 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | VistaPano S 2 (Model: VistaPano S)VistaPano S Ceph 2 (Model: VistaPano S Ceph) | 2012 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | — | 2013 |
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 VATECH Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Mar 2026 | K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | OAS Dental Computed Tomography X-Ray |
| 21 Feb 2025 | K243088 | Green X 12 SE (PHT-40CHS) | OAS Dental Computed Tomography X-Ray |
| 14 Feb 2025 | K243081 | Green X 21 (PHT-90CHO) | OAS Dental Computed Tomography X-Ray |
| 25 Oct 2024 | K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | MUH Digital Extraoral Source X-Ray System |
| 19 Jul 2023 | K231796 | Grreen X 12 (Model: PHT-75CHS) | OAS Dental Computed Tomography X-Ray |
| 26 Oct 2022 | K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | EHD Extraoral with Timer X-Ray Unit |
| 18 Feb 2021 | K210329 | Green X 18(Model : PHT-75CHS) | OAS Dental Computed Tomography X-Ray |
| 25 Jan 2021 | K203797 | vatech A9 (Model : PHT-30CSS) | OAS Dental Computed Tomography X-Ray |
| 27 Oct 2020 | K201627 | Dental Computed Tomography X-Ray System, Green X | OAS Dental Computed Tomography X-Ray |
| 11 Feb 2020 | K200182 | EzRay Air Portable (Model: VEX-P300) | EHD Extraoral with Timer X-Ray Unit |
| 16 Jun 2017 | K170066 | Green16/Green18 (Model: PHT-65LHS) | OAS Dental Computed Tomography X-Ray |
| 4 Apr 2017 | K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight | MUH Digital Extraoral Source X-Ray System |
| 24 Jan 2017 | K163705 | EzRay Air W | EHD Extraoral with Timer X-Ray Unit |
| 28 Oct 2016 | K160882 | PaX-i3D Green Premium (Model: PCT-90LH) | OAS Dental Computed Tomography X-Ray |
| 20 Oct 2016 | K162660 | Green Smart (Model: PHT-35LHS) | OAS Dental Computed Tomography X-Ray |
| 1 Sep 2016 | K161063 | EzRay Air (Model VEX-P300) | EHD Extraoral with Timer X-Ray Unit |
| 23 Oct 2015 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | OAS Dental Computed Tomography X-Ray |
| 7 Aug 2014 | K132983 | TON-95LH, PAX-I3D ORTHO | OAS Dental Computed Tomography X-Ray |
| 15 Jul 2013 | K130585 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 31 May 2013 | K130432 | PHT-6500, PHT-60CFO | OAS Dental Computed Tomography X-Ray |
| 13 Dec 2012 | K123493 | VEX-S 100W INTRAORAL X-RAY SYSTEM | EHD Extraoral with Timer X-Ray Unit |
| 4 Sep 2012 | K122155 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 28 Aug 2012 | K121400 | PAX-UNI3D, PHT-7500 | OAS Dental Computed Tomography X-Ray |
| 8 Jun 2012 | K121412 | PAX-FLEX3D, PHT-7000 | OAS Dental Computed Tomography X-Ray |
| 24 May 2012 | K121236 | PAX-DUO3D PLUS, PCT-5000 | OAS Dental Computed Tomography X-Ray |
| 27 Mar 2012 | K113672 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 25 Mar 2011 | K102196 | COMPUTED TOMOGRAPHY X-RAY SYSTEM | OAS Dental Computed Tomography X-Ray |
| 22 Oct 2010 | K102124 | DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 24 Mar 2010 | K100317 | DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO | MUH Digital Extraoral Source X-Ray System |
| 8 Jan 2010 | K090467 | DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D | OAS Dental Computed Tomography X-Ray |
| 9 Oct 2009 | K092103 | DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) | EHD Extraoral with Timer X-Ray Unit |
| 10 Oct 2008 | K082350 | PAX-500 | OAS Dental Computed Tomography X-Ray |
| 8 Apr 2008 | K073365 | DENTAL DIGITAL X-RAY IMAGING SYSTEM | MUH Digital Extraoral Source X-Ray System |
Also lists devices cleared under other names
VATECH Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Mtechgroup (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Nov 2012 | K122606 | PHT-6500; PHT-60CFO; PAX-I3D | Mtechgroup | OAS Dental Computed Tomography X-Ray |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| VATECH CO., LTD.FDA reg. 3004706313 | Hwaseong-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9065556). 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.