510(k) Report

FDA applicant

Innovation Meditech GmbH

Brea, CA1 decision2013–20130 recalls

FDA records 1 decision for Innovation Meditech GmbH (Brea, CA) in 2013: 1 510(k) clearance. All are in product code EBD (Coating, Filling Material, Resin). 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 Innovation Meditech GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 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 — Innovation Meditech 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?

  • EBDCoating, Filling Material, Resin1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K123761Vita Enamic StainsInnovation Meditech GmbH · 20132cite it

What has FDA decided for it lately?

  • K123761Vita Enamic StainsInnovation Meditech GmbH · 2013

The one decision as Innovation Meditech GmbH →

Other applicant names beginning “Innovation”

FDA records each applicant name separately; these may or may not be the same firm.

Innovation Sports, Inc. 2