FDA applicant
Kettenbach GmbH & Co. KG
FDA records 14 decisions for Kettenbach GmbH & Co. KG (Eschenburg, DE) from 2008 to 2026: 14 510(k) clearances. Most are in product codes ELW (Material, Impression) and EBF (Material, Tooth Shade, Resin). Since 2016 its 510(k)s took a median of 116 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 7 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
How often FDA has decided Kettenbach GmbH & Co. KG’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Kettenbach 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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