510(k) Report

FDA applicant

Graphenano Dental S.L.

Valencia, ES2 decisions2022–20251 recall

FDA records 2 decisions for Graphenano Dental S.L. (Valencia, ES) from 2022 to 2025: 2 510(k) clearances. All are in product code EBF (Material, Tooth Shade, Resin). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 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 Graphenano Dental S.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12025: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2022high 1 (2023) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Graphenano Dental S.L. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220329G-CAMGraphenano Dental S.L. · 20221cites it

What has FDA decided for it lately?

  • K253236G-BlockGraphenano Dental S.L. · 2025
  • K220329G-CAMGraphenano Dental S.L. · 20221 recall

All 2 as Graphenano Dental S.L. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K220329GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95…Oct 24, 2023Class II