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510(k) K231796

Grreen X 12 (Model: PHT-75CHS) by VATECH Co., Ltd. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2023
Date Received
June 20, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
X-Ray, Tomography, Computed, Dental
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

Other clearances by VATECH Co., Ltd.

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  • K243081 — Green X 21 (PHT-90CHO) (February 14, 2025)
  • K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta (October 25, 2024)
  • K223058 — EzRay Air 2 Wall (Model: VEX-S350W) (October 26, 2022)
  • K213462 — EzRay M18 (Model: VMX-P400) (February 11, 2022)
  • K210329 — Green X 18(Model : PHT-75CHS) (February 18, 2021)
  • K203667 — EzRay M (Model: VMX-P300) (February 2, 2021)
  • K203797 — vatech A9 (Model : PHT-30CSS) (January 25, 2021)
  • K201627 — Dental Computed Tomography X-Ray System, Green X (October 27, 2020)
  • K200182 — EzRay Air Portable (Model: VEX-P300) (February 11, 2020)

Other clearances for product code OAS

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  • K253959 — Primevision 3D (February 5, 2026)
  • K251798 — RCT700 (November 25, 2025)
  • K251842 — Dental Computed Tomography X-ray System (November 13, 2025)
  • K250060 — GT300; GT300-C (October 8, 2025)
  • K251642 — Dental CBCT X-ray System (June 27, 2025)
  • K243337 — Dental Cone Beam Computed Tomography System (April 17, 2025)
  • K243903 — RCT600 (March 12, 2025)
  • K243088 — Green X 12 SE (PHT-40CHS) (February 21, 2025)
  • K243081 — Green X 21 (PHT-90CHO) (February 14, 2025)