FDA applicant
Major Prodotti Dentari S.P.A.
FDA records 3 decisions for Major Prodotti Dentari S.P.A. (Monacalieri (Torino), IT) in 2008: 3 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and EBG (Crown And Bridge, Temporary, Resin). Its devices cite 3 predicates, 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
How often FDA has decided Major Prodotti Dentari S.P.A.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2008
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Major Prodotti Dentari S.P.A.’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 “Major”
FDA records each applicant name separately; these may or may not be the same firm.