510(k) Report

FDA applicant

Fona S.R.L

Assago, IT4 decisions2016–20220 recalls

FDA records 4 decisions for Fona S.R.L (Assago, IT) from 2016 to 2022: 4 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and EHD (Unit, X-Ray, Extraoral With Timer). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 69 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 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 Fona S.R.L’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2016: 12021: 12022: 2
2016high 2 (2022) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Fona S.R.L by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MUHSystem, X-Ray, Extraoral Source, Digital2decisions
  • EHDUnit, X-Ray, Extraoral With Timer1decision
  • OASX-Ray, Tomography, Computed, Dental1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 84 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 69 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K222274Fona XDCFona S.R.L · 2022
  • K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L · 2022
  • K212103StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2Fona S.R.L · 2021
  • K161131FONA Pan/CephFona S.R.L · 2016

All 4 as Fona S.R.L →