FDA applicant
Specialites Septodont
FDA records 21 decisions for Specialites Septodont (Washington, DC) from 1985 to 2001: 21 510(k) clearances. Most are in product codes EMA (Cement, Dental) and EJK (Liner, Cavity, Calcium Hydroxide). 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 Specialites Septodont’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Specialites Septodont since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Specialites Septodont’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) Report