Data / Medical devices / Israel / Cortex Dental Implants Industries Ltd.
Cortex Dental Implants Industries Ltd.: FDA-registered device maker in Shlomi Northern, Israel, 4 510(k) clearances
Cortex Dental Implants Industries Ltd. is registered with the FDA (registration 3007842672) in Shlomi Northern, Israel. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 29, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007842672
- Address
- Yaara Street 26, P.O. Box 125, Old Industrial area, Shlomi Northern, Israel, 2283202
- Owner or operator
- Cortex Dental Implants Industries Ltd. (10030174)
- Roles
- Manufacturer
- First device listed
- August 23, 2009
- Registered through
- 2026
- Brand names listed
- BCDL-0833 BCDL-0838 BCDL-0842 BCDL-1033 BCDL-1038 BCDL-1042 MPN-S010 MPW-S010 MPR-0055 MPR-0070 MPW-S006A, BCDL-1133 BCDL-1138 BCDL-1142 BCDL-1333 BCDL-1338 BCDL-1342 BCDL-1633 BCDL-1638 BCDL-1642, BCO-CC309 BCO-CC409 BCO-CC509 BCO-CC218 BCO-CC318 BCO-CC418 BCO-CC518 BCO-CC230 BCO-CC330 BCO-CC430, BCO-CC530 PCO-CC209 PCO-CC309 PCO-CC409 PCO-CC509 PCO-CC218 PCO-CC318 PCO-CC418 PCO-CC518 PCO-CC230, BCO-MU218 BCO-MU318 BCO-MU418 BCO-MU518 BCO-MU230 BCO-MU330 BCO-MU430 BCO-MU530 PCO-MU209 PCO-MU309, BCO-MU230 BCO-MU309 BCO-MU318 BCO-MU330 BCO-MU409 BCO-MU418 BCO-MU430 BCO-MU509 BCO-MU518 BCO-MU530, BCO-MUS1 BCO-MUS2 BCO-MUS3 BCO-MUS4 BCO-MUS5 BCO-MUS6 PCO-MU209 PCO-MU218 PCO-MU230 PCO-MU309, BCO-MUS1 BCO-MUS2 BCO-MUS3 BCO-MUS4 BCO-MUS5 BCO-MUS6 PCO-MUS1 PCO-MUS2 PCO-MUS3 PCO-MUS4 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 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 |
|---|---|---|---|---|---|---|
| January 29, 2019 | K181580 | Cortex CAD/CAM Abutments | NHA | Substantially Equivalent | Cortex Dental Implants Industries , Ltd. | accessdata.fda.gov |
| August 29, 2017 | K163385 | Cortex Dental Implant System | DZE | Substantially Equivalent | Cortex Dental Implants Industries , Ltd. | accessdata.fda.gov |
| March 17, 2014 | K131258 | SATURN DENTAL IMPLANT | DZE | Substantially Equivalent | Cortex Dental Implants Industries , Ltd. | accessdata.fda.gov |
| July 7, 2009 | K090709 | CORTEX DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Cortex Dental Implants Industries , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Drill, Dental, Intraoral
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of Accessories, Implant, Dental, Endosseous
Updated January 29, 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.