Manufacturer registered with FDA
alfa gate - mazen ltd.
kfar qara, Israel. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 3
- 510(k) clearances
- 12019–2019
- Markets registered in
- 314 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name alfa gate - mazen ltd. 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 | alfa gate - mazen ltd. | 1 clearances | 2019–2019 | Below |
| Israel | AMAR | Registration holder | ALFA GATE - MAZEN LTD. | 10 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Alfa-Gate Mazen Ltd. | 4 | — | 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 alfa gate - mazen ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Alfa Gate | 2018 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Alfa Gate | 2019 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Alfa Gate | 2019 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Lister | — | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
alfa gate - mazen ltd. 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: Odontit S.A. (1), Odontit Systeme (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Jan 2008 | K072917 | JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM | Odontit S.A. | DZE Root-Form Endosseous Implant |
| 3 Jun 1992 | K915375 | ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM | Odontit Systeme | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ALFA GATE - MAZEN LTD.FDA reg. 3013701115 | kfar qara Northern, Israel | Foreign exporter, Manufacturer, Private-label distributor, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058549). 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.