Home / 510(k) Clearances / K221525

510(k) K221525

PreXion3D Explorer PRO by Prexion Corporation — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2022
Date Received
May 26, 2022
Clearance Type
Traditional
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 Prexion Corporation

  • K232166 — PreXion3D Expedition (September 8, 2023)
  • K222150 — PreXion3D Expedition (January 12, 2023)
  • K203784 — PreXion3D Explorer PRO (February 23, 2021)
  • K193329 — PreXion3D Explorer EX (April 9, 2020)
  • K190320 — PreXion3D Explorer (April 15, 2019)
  • K181983 — PreXion 3D Excelsior (August 17, 2018)
  • K173878 — PreXion3D Excelsior (January 19, 2018)
  • K161881 — PreXion3D Excelsior (October 3, 2016)

Other clearances for product code OAS

  • K252353 — myray ProXIma X6 (March 10, 2026)
  • 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)