510(k) Report

FDA applicant

Dental Manufacturing S.P.A

Littleton, CO2 decisions2002–20260 recalls

FDA records 2 decisions for Dental Manufacturing S.P.A (Littleton, CO) from 2002 to 2026: 2 510(k) clearances. Most are in product codes ELM (Denture, Plastic, Teeth) and POW (Crown And Bridge, Long-Term Temporary, Resin). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dental Manufacturing S.p.A.”.

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 Dental Manufacturing S.P.A’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dental Manufacturing S.P.A 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?

  • ELMDenture, Plastic, Teeth1decision
  • POWCrown And Bridge, Long-Term Temporary, Resin1decision

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?

  • K261456Ruthinium DiscDental Manufacturing S.p.A. · 2026
  • K013824Acry Plus, Acry Lux, Acry Lux V, Acry Rock, Acry Rock V and Z-Tone Preformed Plastic Denture TeethDental Manufacturing S.P.A · 2002

The one decision as Dental Manufacturing S.P.A →The one decision as Dental Manufacturing S.p.A. →