FDA applicant
Svenska Dental Instruments AB
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
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.
Planning a device like Svenska Dental Instruments AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Svenska”
FDA records each applicant name separately; these may or may not be the same firm.