510(k) Report

FDA applicant

Svenska Dental Instruments AB

Sweden, SE4 decisions1989–20020 recalls

FDA records 4 decisions for Svenska Dental Instruments AB (Sweden, SE) from 1989 to 2002: 4 510(k) clearances. Most are in product codes EKS (File, Pulp Canal, Endodontic) and EGS (Handpiece, Contra- And Right-Angle Attachment…). 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 Svenska Dental Instruments AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Svenska Dental Instruments AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Svenska”

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