Data / Medical devices / Israel / A.B. Dental Devices Ltd
A.B. Dental Devices Ltd: FDA-registered device maker in Ashdod Southern, Israel, 8 510(k) clearances
A.B. Dental Devices Ltd is registered with the FDA (registration 3005663340) in Ashdod Southern, Israel. It lists 7 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005663340
- Address
- 19 Hayahalomim st., Ashdod Southern, Israel, 77609
- Owner or operator
- A.B. DENTAL DEVICES LTD (9085481)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 5, 2006
- Registered through
- 2026
- Brand names listed
- A.B. DENTAL DEVICES Dental Implants System, A.B. Dental Device, Ltd., A.B. Dental Devices, Ltd., AB Dental Devices Dental Implants, AB Guided Surgical Box, AB Guided Surgical Kit, AB LOC H1mm Conical Platform, AB LOC H2mm Conical Platform and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | 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 |
|---|---|---|---|---|---|---|
| June 18, 2026 | K250806 | Dental Implant System | DZE | Substantially Equivalent | A.B. Dental Devices , Ltd. | accessdata.fda.gov |
| September 23, 2022 | K202144 | A.B. Dental Devices Dental Implants System | NHA | Substantially Equivalent | A.B. Dental Device , Ltd. | accessdata.fda.gov |
| July 15, 2019 | K182455 | A.B. DENTAL DEVICES Dental Implants System | NHA | Substantially Equivalent | A.B. Dental Device , Ltd. | accessdata.fda.gov |
| November 23, 2018 | K181381 | A.B. Dental Devices Dental Implants System | NHA | Substantially Equivalent | A.B. Dental Device , Ltd. | accessdata.fda.gov |
| September 15, 2017 | K162482 | A.B. DENTAL DEVICES Dental Implants System | DZE | Substantially Equivalent | A.B. Dental Device , Ltd. | accessdata.fda.gov |
| January 21, 2014 | K132125 | A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM | DZE | Substantially Equivalent | A.B. Dental Devices , Ltd. | accessdata.fda.gov |
| April 18, 2012 | K112440 | AB DENTAL DEVICES IMPLANTS AND ACCESSORIES | DZE | Substantially Equivalent | A.B. Dental Devices , Ltd. | accessdata.fda.gov |
| March 21, 2006 | K051719 | A.B. DENTAL DEVICES | DZE | Substantially Equivalent | A.B. Dental Devices , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Instruments, Dental Hand
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Handle, Instrument, Dental
- All makers of Drill, Dental, Intraoral
- All makers of Elevator, Surgical, Dental
Updated June 18, 2026. 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.