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 IIa | 6 441 |
|---|
Most frequent device types declared: Acrylic resin artificial teeth, Addition curing silicones for dental impressions, Alginates for dental impressions, Cold Curing acrylic resin for temporary crowns and bridges, Cold-curing denture base acrylic resin.
Devices declared under this manufacturer
- ALGINMAX SAMPLE - 1X100G
- MAJOR AF COMP-V X6 LOWER A3,5-L1
- MAJOR DENT NEW-V X6 UPPER A1-3A
- MAJOR PLUS COMP V X6 UPPER D2-M4
- MAJOR PLUS COMP V X8 UPPER B4-T14
- MAJOR PLUS COMP V X8 UPPER C4-T11
- MAJOR PLUS V X6 UPPER B3-S4
- MAJOR PLUS V X8 UPPER B3-T10
- MAJOR PLUS V X8 UPPER B4-HAM
- MAJOR SUPER LUX A1-D4 X6 UPPER A3-1/47
- MAJOR SUPER LUX A1-D4 X8 UPPER C1-T11
- MAJOR SUPER LUX I X6 UPPER 2C-1/17
Showing 12 of 6 441 declared devices.
Catalogue references include A2090, B4112-A2, T2011.B3.S4.U, T2012.B3.T10.U, T2012.B4.HAM.U, T2031.D2.M4.U.
European nomenclature codes declared: Q010699, Q01020101, Q01020102, Q01020104, Q0102050199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MAJOR PRODOTTI DENTARI S.P.A. (IT) · FDA 4565 |
| Devices in EUDAMED | 6 441 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 6 441 |
|---|---|
| Found in the U.S. device database | 2 187 |
| Share | 34.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Major Prodotti Dentari S.p.A. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030075-01 | issued | 2029-04-18 |