Data / Medical devices / Italy / Major Prodotti Dentari S.P.A.
Major Prodotti Dentari S.P.A.: FDA-registered device maker in MONCALIERI Torino, Italy, 4 510(k) clearances
Major Prodotti Dentari S.P.A. is registered with the FDA (registration 4565) in MONCALIERI Torino, Italy. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 9, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 4565
- Address
- Via Luigi Einaudi 23, MONCALIERI Torino, Italy, 10024
- Owner or operator
- MAJOR PRODOTTI DENTARI S.P.A. (9027488)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 16, 2006
- Registered through
- 2026
- Brand names listed
- AVM 100, Algeniux, Alginkid, Alginmajor, Alginmax, Alginplus Fast, Alginplus Tropical, Bambino Tooth and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Articulators | EJP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 9, 2008 | K082700 | TEMPORARY COLD.V AND SELF-CURE DENTINE | EBG | Substantially Equivalent | Major Prodotti Dentari S.P.A. | accessdata.fda.gov |
| November 25, 2008 | K082153 | MAJOR.REPAIR | EBI | Substantially Equivalent | Major Prodotti Dentari S.P.A. | accessdata.fda.gov |
| October 8, 2008 | K081884 | MAJOR.BASE 20 | EBI | Substantially Equivalent | Major Prodotti Dentari S.P.A. | accessdata.fda.gov |
| October 29, 1996 | K963205 | ALGINMAX, ORTHOCHROME | ELW | Substantially Equivalent | American Tooth Industries | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Impression Tray, Resin
- All makers of Material, Impression
- All makers of Articulators
- All makers of Denture, Plastic, Teeth
- All makers of Crown And Bridge, Temporary, Resin
Updated December 9, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.