510(k) Report

FDA applicant

Clinical House Europe GmbH

Las Vegas, NV2 decisions2013–20150 recalls

FDA records 2 decisions for Clinical House Europe GmbH (Las Vegas, NV) from 2013 to 2015: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 5 predicates, 0 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 Clinical House Europe GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013: 12015: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Clinical House Europe GmbH by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K123386Periotype X-PertClinical House Europe GmbH · 20131cites it

What has FDA decided for it lately?

  • K143758PerioType RapidClinical House Europe GmbH · 2015
  • K123386Periotype X-PertClinical House Europe GmbH · 2013

All 2 as Clinical House Europe GmbH →