510(k) Report

FDA applicant

Friadent GmbH

Lake Forest, CA18 decisions1999–20040 recalls

FDA records 18 decisions for Friadent GmbH (Lake Forest, CA) from 1999 to 2004: 18 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and LYC (Bone Grafting Material, Synthetic). Its devices cite 30 predicates, 15 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 Friadent GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Friadent GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Friadent GmbH’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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