Data / Medical devices / Israel / Amg Dental Ltd
Amg Dental Ltd: FDA-registered device maker in Ashdod Southern, Israel, 1 510(k) clearance
Amg Dental Ltd is registered with the FDA (registration 3042227762) in Ashdod Southern, Israel. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 1, 2020. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3042227762
- Address
- 28 Haorgim, Ashdod Southern, Israel, 7760939
- Owner or operator
- AMG Dental Ltd (10094169)
- Roles
- Repackager or relabeler
- First device listed
- November 17, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 1, 2020 | K200188 | DSI Dental Implant System | DZE | Substantially Equivalent | Dsi Dental Solutions, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Irrigation Endosseous Dental Implant Drill Bits
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
Updated April 1, 2020. 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.