510(k) Report

FDA applicant

Asa Instruments S.R.L.

Massarosa (Lucca) Italy, IT1 decision1994–19940 recalls

FDA records 1 decision for Asa Instruments S.R.L. (Massarosa (Lucca) Italy, IT) in 1994: 1 510(k) clearance. All are in product code DYN (Mouthpiece, Saliva Ejector). 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 Asa Instruments S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Asa Instruments S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Asa Instruments S.R.L. 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?

  • DYNMouthpiece, Saliva Ejector1decision

What has FDA decided for it lately?

  • K935616Saliva Ejector DisposableAsa Instruments S.R.L. · 1994

The one decision as Asa Instruments S.R.L. →