FDA applicant

Bredent GmbH & Co. KG

Senden, DE3 decisions2010–20240 recalls

FDA records 3 decisions for Bredent GmbH & Co. KG (Senden, DE) from 2010 to 2024: 3 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EBD (Coating, Filling Material, Resin). Its devices cite 4 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 Bredent GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Bredent GmbH & Co. KG by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Bredent”

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

Bredent-Products For the Dental Technician Laborat 3

Bredent GmbH & Co. KG

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Bredent”