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510(k) K230505

Orthopantomograph™ OP 3D LX by Palodex Group OY — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2023
Date Received
February 24, 2023
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 Palodex Group OY

  • K241249 — Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) (September 12, 2024)
  • K180947 — Orthopantomograph OP 3D (June 7, 2018)
  • K173646 — FS Ergo (December 19, 2017)
  • K163423 — Orthopantomograph OP300 (August 31, 2017)
  • K162799 — Cliniview (April 25, 2017)
  • K170813 — ORTHOPANTOMOGRAPH OP 3D (April 7, 2017)
  • K133544 — OP300 (March 26, 2014)
  • K130297 — SCANORA 3DX (May 29, 2013)
  • K122018 — OP300 (December 10, 2012)

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)