510(k) Report

FDA applicant

Kohler Medizintechnik GmbH & Co. KG

Neuhausen, DE1 decision1998–19980 recalls

FDA records 1 decision for Kohler Medizintechnik GmbH & Co. KG (Neuhausen, DE) in 1998: 1 510(k) clearance. All are in product code EBI (Resin, Denture, Relining, Repairing, Rebasing). 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 Kohler Medizintechnik GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kohler Medizintechnik GmbH & Co. KG since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Kohler”

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