Data / Medical devices / Israel / Alfa Gate - Mazen Ltd.
Alfa Gate - Mazen Ltd.: FDA-registered device maker in kfar qara Northern, Israel, 3 510(k) clearances
Alfa Gate - Mazen Ltd. is registered with the FDA (registration 3013701115) in kfar qara Northern, Israel. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 3, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013701115
- Address
- hitin st2, kfar qara Northern, Israel, 3007500
- Owner or operator
- alfa gate - mazen ltd. (10058549)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
- First device listed
- October 9, 2018
- Registered through
- 2026
- Brand names listed
- Alfa Gate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Exporter to the US, Foreign private label distributor, 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 |
|---|---|---|---|---|---|---|
| October 3, 2019 | K182143 | ALFA GATE Dental Implants System | DZE | Substantially Equivalent | Alfa Gate Mazen, Ltd. | accessdata.fda.gov |
| January 14, 2008 | K072917 | JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM | DZE | Substantially Equivalent | Odontit S.A. | accessdata.fda.gov |
| June 3, 1992 | K915375 | ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM | DZE | Substantially Equivalent | Odontit Systeme | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Dental, Intraoral
- All makers of Implant, Endosseous, Root-Form
- All makers of Implant, Endosseous, Orthodontic
- All makers of Abutment, Implant, Dental, Endosseous
Updated October 3, 2019. 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.