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510(k) K170813

ORTHOPANTOMOGRAPH OP 3D by Palodex Group OY — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2017
Date Received
March 17, 2017
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

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  • K230505 — Orthopantomograph™ OP 3D LX (June 9, 2023)
  • K180947 — Orthopantomograph OP 3D (June 7, 2018)
  • K173646 — FS Ergo (December 19, 2017)
  • K163423 — Orthopantomograph OP300 (August 31, 2017)
  • K162799 — Cliniview (April 25, 2017)
  • K133544 — OP300 (March 26, 2014)
  • K130297 — SCANORA 3DX (May 29, 2013)
  • K122018 — OP300 (December 10, 2012)

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  • 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)