Data / Medical devices / Israel / Ditron Dental Ltd
Ditron Dental Ltd: FDA-registered device maker in Ashkelon Southern, Israel, 4 510(k) clearances
Ditron Dental Ltd is registered with the FDA (registration 3010948854) in Ashkelon Southern, Israel. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010948854
- Address
- 2 Haofe St. Southern Industrial Zone, Ashkelon Southern, Israel, 7878002
- Owner or operator
- Ditron Dental Ltd (10049877)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 19, 2015
- Registered through
- 2026
- Brand names listed
- Abutment multi post screw, Multi-unit abutment screw, Multi-unit prosthetic screw., Abutment, Implant, Dental Endosseous, Accelx cover screws, Accelx dental implants, Bar Retained Abutments, Multi-Unit Bar Retained Abutments, Screw Retained Abutment, Cover Screw, Healing Cap, CC Cement Retained Abutments, CC Cover Screw, CC Healing Caps and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dental Implant Surgical Tray | OFY | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| December 16, 2024 | K243066 | Dental Implants and Abutments | DZE | Substantially Equivalent | Ditron Dental, Ltd. | accessdata.fda.gov |
| April 30, 2024 | K233231 | Dental Implants and Abutments | DZE | Substantially Equivalent | Ditron Dental, Ltd. | accessdata.fda.gov |
| October 28, 2016 | K161497 | Dental Implants and Abutments | DZE | Substantially Equivalent | Ditron Precision, Ltd. | accessdata.fda.gov |
| October 17, 2014 | K140728 | MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR | DZE | Substantially Equivalent | Ditron Precision, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Dental Implant Surgical Tray
- All makers of Accessories, Implant, Dental, Endosseous
Updated December 16, 2024. 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.