EU → US Device Access

Major Prodotti Dentari S.p.A.

IT-MF-000024700 · Italy · Moncalieri (TO)

Major Prodotti Dentari S.p.A. is registered in the European database on medical devices as a manufacturer, with 6 441 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6 441

Most frequent device types declared: Acrylic resin artificial teeth, Multilayer composite and acrylic resin artificial teeth, Alginates for dental impressions, Heat-polymerizable denture base polymer, Cold-curing denture base acrylic resin.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMAJOR PRODOTTI DENTARI S.P.A. (IT) · FDA 4565
Devices in EUDAMED6 441
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
0425-MDR-030075-01issued2029-04-18

Other manufacturers in Italy

All Italy manufacturers →