510(k) Report

FDA applicant

Nouvag AG

Gebenstorf, CH12 decisions1996–20260 recalls

FDA records 12 decisions for Nouvag AG (Gebenstorf, CH) from 1996 to 2026: 12 510(k) clearances. Most are in product codes EFB (Handpiece, Air-Powered, Dental) and EKX (Handpiece, Direct Drive, Ac-Powered). Its devices cite 16 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 Nouvag AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12008: 12009: 12026 (partial year): 1
2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nouvag AG 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?

  • EFBHandpiece, Air-Powered, Dental3decisions
  • EKXHandpiece, Direct Drive, Ac-Powered2decisions
  • EFAHandpiece, Belt And/Or Gear Driven, Dental1decision
  • FRNPump, Infusion1decision
  • BTAPump, Portable, Aspiration (Manual Or Powered)1decision
  • DZIDrill, Bone, Powered1decision

Also: EGS (1), HET (1), QPB (1).

Whose devices does it build on?

Its devices cite 16 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 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.

  • K042822TCM Endo V, Model 1534Nouvag AG · 20043cite it
  • K042943Nouvag AG - Vacuson 40 and Vacuson 60Nouvag AG · 20042cite it
  • K013185TCM Endo IiiNouvag AG · 20011cites it
  • K954722Micro-Dispenser 7000 & Microdispenser 8000Nouvag AG · 19961cites it
  • K042434Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55Nouvag AG · 20041cites it
  • K981679TCM 3000 and TCM EndoNouvag AG · 19991cites it

What has FDA decided for it lately?

  • K254135LipoSurg ARTISTNouvag AG · 2026
  • K080365Morce Power Plus and Variocarve MorcellatorNouvag AG · 2009
  • K081191TCM Endo 20Nouvag AG · 2008
  • K071588Dispenser DP 20Nouvag AG · 2007
  • K042822TCM Endo V, Model 1534Nouvag AG · 2004
  • K042943Nouvag AG - Vacuson 40 and Vacuson 60Nouvag AG · 2004
  • K042434Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55Nouvag AG · 2004
  • K022505Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066…Nouvag AG · 2003

All 12 as Nouvag AG →