Data / Medical devices / Israel / Bioline Dental Implant Systems Ltd
Bioline Dental Implant Systems Ltd: FDA-registered device maker in Migdal Tefen Northern, Israel, 1 510(k) clearance
Bioline Dental Implant Systems Ltd is registered with the FDA (registration 3014329459) in Migdal Tefen Northern, Israel. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014329459
- Address
- 1 Haella St Tefen Industrial Park POB 70, Migdal Tefen Northern, Israel, 2495900
- Owner or operator
- Bioline Dental Implant Systems Ltd (10092547)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 19, 2025
- Registered through
- 2026
- Brand names listed
- Bioline Dental Implant System, Cortical Drill, Countersink Drill, Depth Probe, Digital Analog, Digital Analog for Slim Connection, Drill Extension, Driver Hex and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Manufacturer | accessdata.fda.gov |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | 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, 2025 | K250872 | Bioline Dental Implant System | DZE | Substantially Equivalent | Bioline Dental Implant Systems, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Non-Irrigation Endosseous Dental Implant Drill Bits
- All makers of Bur, Dental
- All makers of Instrument, Diamond, Dental
Updated June 18, 2025. 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.