Grreen X 12 (Model: PHT-75CHS)
FDA 510(k) K231796 · VATECH Co., Ltd.
510(k) numberK231796
Submission
- Device name
- Grreen X 12 (Model: PHT-75CHS)
- Applicant
- VATECH Co., Ltd.
Hwaseong-Si, KR - Received
- June 20, 2023
- Decision date
- July 19, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code OAS
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| K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series)OAS · Traditional | Hefei Meyer Optoelectronic Technology, Inc. | 07/23/2026SE |
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| K260662 | Dental Cone Beam Computed Tomography SystemOAS · Special | Yofo Medical Technology Co., Ltd. | 06/04/2026SE |
| K253935 | medXion NEXUSOAS · Traditional | medXion Technologies, Inc. | 05/15/2026SE |
| K260462 | RCT800OAS · Special | Ray Co., Ltd. | 04/09/2026SE |
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS · Special | VATECH Co., Ltd. | 03/31/2026SE |
| K252353 | myray ProXIma X6OAS · Traditional | Cefla S.C. | 03/10/2026SE |
| K253959 | Primevision 3DOAS · Traditional | Dentsply Sirona | 02/05/2026SE |
| K251798 | RCT700OAS · Traditional | Ray Co., Ltd. | 11/25/2025SE |
| K251842 | Dental Computed Tomography X-ray SystemOAS · Traditional | Fussen Technology Co., Ltd. | 11/13/2025SE |
More from Fussen Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS · Special | 03/31/2026SE |
| K243088 | Green X 12 SE (PHT-40CHS)OAS · Special | 02/21/2025SE |
| K243081 | Green X 21 (PHT-90CHO)OAS · Traditional | 02/14/2025SE |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…MUH · Traditional | 10/25/2024SE |
| K223058 | EzRay Air 2 Wall (Model: VEX-S350W)EHD · Special | 10/26/2022SE |
| K213462 | EzRay M18 (Model: VMX-P400)IZL · Traditional | 02/11/2022SE |
| K210329 | Green X 18(Model : PHT-75CHS)OAS · Special | 02/18/2021SE |
| K203667 | EzRay M (Model: VMX-P300)IZL · Traditional | 02/02/2021SE |
| K203797 | vatech A9 (Model : PHT-30CSS)OAS · Special | 01/25/2021SE |
| K201627 | Dental Computed Tomography X-Ray System, Green XOAS · Traditional | 10/27/2020SE |
Questions and answers
When was Grreen X 12 (Model: PHT-75CHS) cleared by the FDA?
Grreen X 12 (Model: PHT-75CHS) (K231796) received a 510(k) decision of Substantially Equivalent on July 19, 2023, 29 days after the submission was received.
What is the product code of K231796?
The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.