510(k) Report

FDA applicant

Friatec AG

Potomac, MD6 decisions1998–19980 recalls

FDA records 6 decisions for Friatec AG (Potomac, MD) in 1998: 6 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and JEY (Plate, Bone). Its devices cite 1 predicate, 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 Friatec AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Friatec AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Friatec”

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