510(k) Report

FDA applicant

3M Espe AG Dental Products

Bavaria D-82228 Seefeld, DE24 decisions2002–20100 recalls

FDA records 24 decisions for 3M Espe AG Dental Products (Bavaria D-82228 Seefeld, DE) from 2002 to 2010: 24 510(k) clearances. Most are in product codes KLE (Agent, Tooth Bonding, Resin) and EMA (Cement, Dental). Its devices cite 72 predicates, 22 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 3M Espe AG Dental Products’s devices, and how often a recall has named them.

FDA decisions per year

4in 2010

2007: 22008: 32009: 22010: 4
2007high 4 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 3M Espe AG Dental Products by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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