510(k) Report

FDA applicant

Planmeca Oy

Helsinki, FI28 decisions1993–20230 recalls

FDA records 28 decisions for Planmeca Oy (Helsinki, FI) from 1993 to 2023: 28 510(k) clearances. Most are in product codes EHD (Unit, X-Ray, Extraoral With Timer) and MUH (System, X-Ray, Extraoral Source, Digital). Since 2016 its 510(k)s took a median of 187 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 11 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Planmeca Oy’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 12009: 12010: 12011: 12014: 12016: 12017: 12018: 12020: 12023: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Planmeca Oy by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EHDUnit, X-Ray, Extraoral With Timer13decisions
  • MUHSystem, X-Ray, Extraoral Source, Digital5decisions
  • OASX-Ray, Tomography, Computed, Dental3decisions
  • EIAUnit, Operative Dental3decisions
  • LLZSystem, Image Processing, Radiological3decisions
  • KLCChair, Dental, With Operative Unit1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 187 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 30 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060328Planmeca Promax 3DPlanmeca Oy · 20067cite it
  • K093590Planmeca Promax 3D MaxPlanmeca Oy · 20104cite it
  • K011619Promax, Panoramic X-Ray Unit with CephalostatPlanmeca Oy · 20013cite it
  • K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy · 20162cite it
  • K970975Prostyle IntraPlanmeca Oy · 19972cite it
  • K200572Planmeca RomexisPlanmeca Oy · 20202cite it

What has FDA decided for it lately?

  • K230985Planmeca VisoPlanmeca Oy · 2023
  • K200572Planmeca RomexisPlanmeca Oy · 2020
  • K181576Planmeca VisoPlanmeca Oy · 2018
  • K171385Planmeca RomexisPlanmeca Oy · 2017
  • K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy · 2016
  • K140713Planmeca RomexisPlanmeca Oy · 2014
  • K103689Planmeca Promax 3D MidPlanmeca Oy · 2011
  • K093590Planmeca Promax 3D MaxPlanmeca Oy · 2010

All 28 as Planmeca Oy →

Other applicant names beginning “Planmeca”

FDA records each applicant name separately; these may or may not be the same firm.

Planmeca USA, Inc. 13