Manufacturer registered with FDA
Bioline Dental Implant Systems Ltd
Migdal Tefen, Israel. Lists 6 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 6
- Brands and models
- 24
- 510(k) clearances
- 12025–2025
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Bioline Dental Implant Systems Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Bioline Dental Implant Systems Ltd | 1 clearances | 2025–2025 | Below |
| Israel | AMAR | Registration holder | BIOLINE DENTAL IMPLANT SYSTEMS LTDBioLine Dental Implant Systems Ltd | 3 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Bioline Dental Implant Systems Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Bioline Dental Implant System | 2025 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | FG Diamond Dental Burs | 2025 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | FG Dental Burs | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Depth ProbeDigital AnalogDigital Analog for Slim ConnectionDriver HexDriver Hex LongDriver Hex shortScan BodyScan Body for Conical ConnectionScan Body for Slim ConnectionSlim Hex Driver 2 moreSurgical Screw DriverTorque Ratchet | 2025 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Bioline Dental Implant System | 2025 |
| Non-Irrigation Endosseous Dental Implant Drill BitsQRQ · Class 1 | Implant instruments & surgical kits | Maker | Cortical DrillCountersink DrillDrill ExtensionGuided Surgery DrillPterygoid Implants DrillStep DrillTrephine DrillZygomatic Implants Drill | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOLINE DENTAL IMPLANT SYSTEMS LTDFDA reg. 3014329459 | Migdal Tefen Northern, Israel | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092547). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.