510(k) Report

FDA applicant

Pressing DI Monticelli Rag. Stefano

Cattilica, IT2 decisions1995–19980 recalls

FDA records 2 decisions for Pressing DI Monticelli Rag. Stefano (Cattilica, IT) from 1995 to 1998: 2 510(k) clearances. Most are in product codes EHP (Clasp, Preformed) and EBI (Resin, Denture, Relining, Repairing, Rebasing). Its devices cite 1 predicate, 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 Pressing DI Monticelli Rag. Stefano’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pressing DI Monticelli Rag. Stefano since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pressing DI Monticelli Rag. Stefano 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?

  • EHPClasp, Preformed1decision
  • EBIResin, Denture, Relining, Repairing, Rebasing1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K973542MASKYPressing DI Monticelli Rag. Stefano · 1998
  • K955946Acetal Dental/Preformed ClaspPressing DI Monticelli Rag. Stefano · 1995

All 2 as Pressing DI Monticelli Rag. Stefano →