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510(k) K180918

Planmed Verity by Planmed OY — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2018
Date Received
April 9, 2018
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 Planmed OY

  • K250318 — Planmed XFI (September 26, 2025)
  • K211720 — Planmed Clarity 2D, Planmed Clarify S (July 18, 2022)
  • K213278 — Planmed Verity (April 28, 2022)
  • K192317 — Planmed Clarity 2D and Clarity S (October 23, 2020)
  • K163328 — Planmed Clarity (December 28, 2017)
  • K143435 — Planmed Verity (May 14, 2015)
  • K121418 — PLANMED VERITY (February 1, 2013)
  • K121963 — PLANMED NUANCE DIGIGUIDE (November 21, 2012)
  • K042671 — PLANMED SOPHIE NUANCE CLASSIC (November 19, 2004)
  • K021945 — PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) (February 21, 2003)

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