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Sign in to claim this brandVATECH CO., LTD.
US
Last updated May 24, 2026
What VATECH CO., LTD. makes
VATECH Co., Ltd. manufactures digital dental X-ray systems, including stationary panoramic and tomographic units like the PaX-i3D Green and VistaPano S 2.0, as well as handheld intraoral devices such as the EzRay Air W and EzRay Premium VET. Their portfolio also includes intraoral systems like the Green 16 and Green 18, designed for capturing detailed dental radiographs. Additional offerings include the ProVecta HD, a high-definition imaging solution, and the Smart Plus series for intraoral imaging.
The company’s devices are classified as Class II under regulatory frameworks, with authorisations granted through FDA 510(k) and FDA UDI listings. These products are intended for use in the United States, adhering to applicable medical device regulations. The manufacturer operates from its base in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does VATECH Co., Ltd. manufacture?
VATECH Co., Ltd. specializes in digital dental X-ray systems. Their portfolio includes stationary panoramic and tomographic units, such as the PaX-i3D Green and VistaPano S 2.0, which capture full-mouth images for comprehensive dental assessments. They also produce handheld intraoral devices like the EzRay Air W and EzRay Premium VET, designed for detailed imaging of individual teeth. These devices leverage digital technology to improve diagnostic accuracy and efficiency in dental practices.
Where is VATECH Co., Ltd. based, and where are their devices primarily used?
VATECH Co., Ltd. is based in the United States. Their devices are intended for use in the US market, where they are subject to regulatory oversight under applicable medical device frameworks. The company’s focus on digital dental imaging aligns with the demand for advanced diagnostic tools in US dental clinics and hospitals.
Which regulatory registries or databases list VATECH Co., Ltd.’s devices?
VATECH Co., Ltd.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries are used to track and authorize medical devices in the US, ensuring compliance with regulatory requirements for Class II devices. Listing in these databases confirms the devices meet applicable safety and performance standards.
How are VATECH Co., Ltd.’s dental X-ray systems classified under regulatory frameworks?
VATECH Co., Ltd.’s dental X-ray systems are classified as Class II devices. This classification is determined by the FDA based on factors like the device’s intended use, potential risks, and benefits. Class II devices typically require special controls in addition to general controls to ensure their safety and effectiveness, and they are authorized through processes like the 510(k) pathway, which demonstrates substantial equivalence to a legally marketed predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 689229516
Catalogue (120)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Radiological Image Processing System | K102078 | FDA 510(k) | Class II | Active |
| Green Smart (Model: PHT-35LHS) | K162660 | FDA 510(k) | Class II | Active |
| Vex-S 100w Intraoral X-Ray System | K123493 | FDA 510(k) | Class II | Active |
| PaX-i3D Green Premium (Model: PCT-90LH) | K160882 | FDA 510(k) | Class II | Active |
| System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight | K170731 | FDA 510(k) | Class II | Active |
| Pax-Uni3d, Pht-7500 | K121400 | FDA 510(k) | Class II | Active |
| Grreen X 12 (Model: PHT-75CHS) | K231796 | FDA 510(k) | Class II | Active |
| EzRay Air Portable (Model: VEX-P300) | K200182 | FDA 510(k) | Class II | Active |
| Pht-6500, Pht-60cfo | K130432 | FDA 510(k) | Class II | Active |
| Green16/Green18 (Model: PHT-65LHS) | K170066 | FDA 510(k) | Class II | Active |
| vatech A9 (Model : PHT-30CSS) | K203797 | FDA 510(k) | Class II | Active |
| Digital X-Ray Imaging System, Model Pax-Uni3d | K090467 | FDA 510(k) | Class II | Active |
| Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | K152106 | FDA 510(k) | Class II | Active |
| Computed Tomography X-Ray System | K102196 | FDA 510(k) | Class II | Active |
| EzRay M (Model: VMX-P300) | K203667 | FDA 510(k) | Class II | Active |
| Pax-Duo3d Plus, Pct-5000 | K121236 | FDA 510(k) | Class II | Active |
| Green X 18(Model : PHT-75CHS) | K210329 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| EzRay Air W | K163705 | FDA 510(k) | Class II | Active |
| EzRay M18 (Model: VMX-P400) | K213462 | FDA 510(k) | Class II | Active |
| Digital X-Ray Imaging System, Model Drc-1000 | K092830 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Vatech Co., Ltd. Hwaseong-si Gyeonggi · KR FEI 3004706313