510(k) Report

FDA applicant

Mectron S.P.A.

Carasco, IT13 decisions2009–20250 recalls

FDA records 13 decisions for Mectron S.P.A. (Carasco, IT) from 2009 to 2025: 13 510(k) clearances. Most are in product codes DZI (Drill, Bone, Powered) and ELC (Scaler, Ultrasonic). Since 2016 its 510(k)s took a median of 197 days from receipt to decision, against 290 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 10 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 Mectron S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 12011: 12012: 12013: 12014: 12015: 22016: 12018: 22023: 12024: 12025: 1
2009high 2 (2015) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Mectron S.P.A. by year, 2009–2026Sources: 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, Powered5decisions
  • ELCScaler, Ultrasonic4decisions
  • JDXInstrument, Surgical, Sonic And Accessory/Attachment2decisions
  • KOJAirbrush1decision
  • EBZActivator, Ultraviolet, For Polymerization1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 197 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 290 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 18 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 10 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.

  • K122322Piezosurgery TouchMectron S.P.A. · 20124cite it
  • K102218Compact Piezo P2K, PowercareMectron S.P.A. · 20112cite it
  • K151248Piezosurgery WhiteMectron S.P.A. · 20152cite it
  • K140965Multipiezo Pro, MultipiezoMectron S.P.A. · 20142cite it
  • K132848Piezosurgery FlexMectron S.P.A. · 20132cite it
  • K153743Piezosurgery PlusMectron S.P.A. · 20162cite it

What has FDA decided for it lately?

  • K251425turbodent touchMectron S.P.A. · 2025
  • K242432MT-BoneMectron S.P.A. · 2024
  • K231391Combi TouchMectron S.P.A. · 2023
  • K171326Piezosurgery WhiteMectron S.P.A. · 2018
  • K171958Piezosurgery Touch, Piezosurgery WhiteMectron S.P.A. · 2018
  • K153743Piezosurgery PlusMectron S.P.A. · 2016
  • K151248Piezosurgery WhiteMectron S.P.A. · 2015
  • K151023Compact Piezo LedMectron S.P.A. · 2015

All 13 as Mectron S.P.A. →