510(k) Report

FDA applicant

Piezosurgery S.R.L.

Rome, IT4 decisions2005–20090 recalls

FDA records 4 decisions for Piezosurgery S.R.L. (Rome, IT) from 2005 to 2009: 4 510(k) clearances. Most are in product codes DZI (Drill, Bone, Powered) and JDX (Instrument, Surgical, Sonic And…). Its devices cite 6 predicates, 2 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 Piezosurgery S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Piezosurgery 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?

  • DZIDrill, Bone, Powered2decisions
  • JDXInstrument, Surgical, Sonic And Accessory/Attachment1decision
  • ELCScaler, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 2 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.

  • K043408Piezosurgery DevicePiezosurgery S.R.L. · 20055cite it
  • K083284Piezosurgery MedicalPiezosurgery S.R.L. · 20092cite it
  • K091227Piezosurgery 3; Osstem PiezoPiezosurgery S.R.L. · 20092cite it
  • K052518PiezosurgeryPiezosurgery S.R.L. · 20051cites it

What has FDA decided for it lately?

  • K091227Piezosurgery 3; Osstem PiezoPiezosurgery S.R.L. · 2009
  • K083284Piezosurgery MedicalPiezosurgery S.R.L. · 2009
  • K052518PiezosurgeryPiezosurgery S.R.L. · 2005
  • K043408Piezosurgery DevicePiezosurgery S.R.L. · 2005

All 4 as Piezosurgery S.R.L. →