510(k) Report

FDA applicant

Cavex Holland BV

Haarlem, NL26 decisions1998–20150 recalls

FDA records 26 decisions for Cavex Holland BV (Haarlem, NL) from 1998 to 2015: 26 510(k) clearances. Most are in product codes ELW (Material, Impression) and EBF (Material, Tooth Shade, Resin). Its devices cite 8 predicates, 8 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 Cavex Holland BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12008: 12014: 12015: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cavex Holland BV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cavex Holland BV’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • ELWMaterial, Impression16decisions
  • EBFMaterial, Tooth Shade, Resin6decisions
  • KLEAgent, Tooth Bonding, Resin2decisions
  • EMACement, Dental1decision
  • EMBZinc Oxide Eugenol1decision

Who builds on its devices?

Later devices cite its devices 9 times; 8 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.

  • K051207Cavex OrthotraceCavex Holland BV · 20052cite it
  • K011419Cavex ColorchangeCavex Holland BV · 20012cite it
  • K023466Tulip Alginate Impression MaterialCavex Holland BV · 20022cite it
  • K032116Tulip ColorswitchCavex Holland BV · 20031cites it
  • K981970Algetral, Cavex Chromatic, CA 37 Superior Pink, CA 37 Fast Set, Cavex Rainbow, Cavex Impressional Normal…Cavex Holland BV · 19981cites it
  • K013336Xantalgin CronoCavex Holland BV · 20011cites it

What has FDA decided for it lately?

  • K151535Cavex Cream AlginateCavex Holland BV · 2015
  • K141092MARK3Cavex Holland BV · 2014
  • K073539Provisa CemCavex Holland BV · 2008
  • K072245Emulate AdvancedCavex Holland BV · 2007
  • K062400Impressix, Colorchange AlginateCavex Holland BV · 2006
  • K061267Simulate, Color Change AlginateCavex Holland BV · 2006
  • K052455ImpressixCavex Holland BV · 2005
  • K051207Cavex OrthotraceCavex Holland BV · 2005

All 26 as Cavex Holland BV →