FDA applicant

Espe GmbH & Co. Kg.

Seefeld, DE17 decisions1995–19980 recalls

FDA records 17 decisions for Espe GmbH & Co. Kg. (Seefeld, DE) from 1995 to 1998: 17 510(k) clearances. Most are in product codes ELW (Material, Impression) and EBF (Material, Tooth Shade, Resin). Its devices cite 17 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 Espe GmbH & Co. Kg.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Espe GmbH & Co. Kg. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Espe GmbH & Co. Kg. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Espe GmbH & Co. Kg.’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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Other applicant names beginning “Espe”

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

Espe GmbH (Us) 59 Espe Dental AG 29 Espe-Premier Sales Co. 10 Espe Dental Products 8 Espe Dental-Medizin GmbH & Co.Kg. 1

Espe 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 “Espe”