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Sign in to claim this brandBIOLINE DENTAL IMPLANT SYSTEMS LTD
US
Last updated May 23, 2026
What BIOLINE DENTAL IMPLANT SYSTEMS LTD makes
Bioline Dental Implant Systems Ltd manufactures reusable diamond dental burs and dental implant systems, including guided surgery drills and step drills. Their product line includes FG Dental Burs for precision dental procedures.
The company’s devices are regulated under FDA Class I and Class II classifications, with submissions recorded in the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bioline Dental Implant Systems Ltd manufacture?
Bioline Dental Implant Systems Ltd specializes in dental devices, primarily producing reusable diamond dental burs and dental implant systems. Their product line includes tools like guided surgery drills and step drills, as well as FG Dental Burs designed for precision dental procedures. These devices are engineered for use in oral surgery and restorative dentistry.
Where is Bioline Dental Implant Systems Ltd based?
The company is headquartered in the United States. This location influences its regulatory compliance, as its devices are subject to FDA oversight under U.S. medical device regulations.
Which regulatory registries list Bioline Dental Implant Systems Ltd’s devices?
Bioline Dental Implant Systems Ltd’s devices are recorded in the FDA’s 510(k) premarket notification program and the FDA’s Unique Device Identification (UDI) system. These registries track submissions and compliance for Class I and Class II devices, ensuring traceability and regulatory transparency.
How are Bioline Dental Implant Systems Ltd’s devices classified under FDA regulations?
Bioline Dental Implant Systems Ltd’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 532209134
Catalogue (267)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FG Dental Burs | 878/014 | FDA UDI | Class I | Active |
| FG Dental Burs | 868/012 | FDA UDI | Class I | Active |
| FG Dental Burs | 856/016 | FDA UDI | Class I | Active |
| FG Dental Burs | 850/025 | FDA UDI | Class I | Active |
| Scan Body for Slim Connection | 4.2mm Diameter x 9mm Length | FDA UDI | Class I | Active |
| FG Dental Burs | 834KR/016 | FDA UDI | Class I | Active |
| FG Dental Burs | 805/012 | FDA UDI | Class I | Active |
| FG Dental Burs | 830/010 | FDA UDI | Class I | Active |
| FG Dental Burs | 877K/012 | FDA UDI | Class I | Active |
| Zygomatic Implant Drill | 4mm Diameter x 95mm Length | FDA UDI | Class I | Active |
| FG Dental Burs | 802/014 | FDA UDI | Class I | Active |
| FG Dental Burs | 845/016 | FDA UDI | Class I | Active |
| FG Dental Burs | 413/020 | FDA UDI | Class I | Active |
| Zygomatic Implant Drill | 3.8mm Diameter x 75mm Length | FDA UDI | Class I | Active |
| FG Dental Burs | 845/012 | FDA UDI | Class I | Active |
| FG Dental Burs | 909/050 | FDA UDI | Class I | Active |
| Bioline Dental Implant System | K250872 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bioline Dental Implant Systems Ltd Migdal Tefen Northern · IL FEI 3014329459