Manufacturer registered with FDA
Major Prodotti Dentari S.P.A.
MONCALIERI, Italy. Lists 6 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 33
- 510(k) clearances
- 32008–2008
- Markets registered in
- 1259 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2000–2026
Registered in 12 markets
Where regulators' registries name Major Prodotti Dentari S.P.A. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Major Prodotti Dentari S.P.A. | 3 clearances | 2008–2008 | Below |
| Saudi Arabia | SFDA | Manufacturer | Major Prodotti Dentari SpA | 20 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Major Prodotti Dentari S.p.A. | 11 | 2024–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Major Prodotti Dentari S.p.A. | 10 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MAJOR PRODOTTI DENTARI S.p.A. | 4 | 2019–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Major Prodotti Dentari S.p.A.MAJOR PRODOTTI DENTARI S.P.A. | 4 | 2006–2016 | Pure Global AI |
| Australia | TGA | Manufacturer | Major Prodotti Dentari SPAMajor prodotti Dentari SPA | 3 | 2004–2013 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MAJOR PRODOTTI DENTARI S.P.A | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MAJOR PRODOTTI DENTARI S.P.A. | 1 | 2026–2026 | Pure Global AI |
| China | NMPA | Registration holder | 美捷牙科医疗公司MAJOR PRODOTTI DENTARI S.p.A. | 1 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | MAJOR PRODOTTI DENTARI | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | MAJOR Prodotti Dentari S.p.A. | 1 | 2012–2012 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Major Prodotti Dentari S.P.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Light-Cure.Traymajor.trayMIT Light-Cure.Tray | 2008 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | major.base 20major.repair | 2008 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | AlgeniuxAlginkidAlginmajorAlginmaxAlginplus FastAlginplus TropicalMichelangelo AlginateOrmactivatorOrmadent PuttyOrmalab 75 9 moreOrmalab 85Ormalab 95OrmamaxOrmaplusOrmaplus labOrthochromePointech NormalPointech OrthodonticValuline | 2006 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | self-cure.dentinetemporary.cold.v | 2009 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Lister | AVM 100 | 2008 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Bambino ToothMajor AF CompMajor DentMajor PlusMajor Plus CompMajor Super Lux | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Major Prodotti Dentari S.P.A. as the applicant.
Also lists devices cleared under other names
Major Prodotti Dentari S.P.A. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: American Tooth Industries (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Oct 1996 | K963205 | ALGINMAX, ORTHOCHROME | American Tooth Industries | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MAJOR PRODOTTI DENTARI S.P.A.FDA reg. 4565 | MONCALIERI Torino, Italy | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9027488). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.