510(k) Report

FDA applicant

Micerium S.P.A.

Avegno, Genoa, IT6 decisions2006–20110 recalls

FDA records 6 decisions for Micerium S.P.A. (Avegno, Genoa, IT) from 2006 to 2011: 6 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and EBF (Material, Tooth Shade, Resin). Its devices cite 10 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 Micerium S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12008: 12011: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Micerium S.P.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form1decision
  • EBFMaterial, Tooth Shade, Resin1decision
  • EBIResin, Denture, Relining, Repairing, Rebasing1decision
  • DYHAdhesive, Bracket And Tooth Conditioner, Resin1decision
  • EBGCrown And Bridge, Temporary, Resin1decision
  • EMACement, Dental1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K062367Miniscrews Anchoring System, M.a.S.Micerium S.P.A. · 20061cites it

What has FDA decided for it lately?

  • K103474Ena Temp and Enamel Plus Temp (Two Different Proprietary Names for the Same Product)Micerium S.P.A. · 2011
  • K072978Tender Ortho Bond-Ena Bond-Ena EtchMicerium S.P.A. · 2008
  • K063170Tender FiberMicerium S.P.A. · 2007
  • K062355Ena CemMicerium S.P.A. · 2006
  • K062367Miniscrews Anchoring System, M.a.S.Micerium S.P.A. · 2006
  • K062906Ena Hfo Composite SystemMicerium S.P.A. · 2006

All 6 as Micerium S.P.A. →